What does compliance of a product with USP-NF standards entail?

How much can I modify a chromatographic procedure and still be in

compliance? Can column length, internal diameter, mobile phase composition be
modified?
What brand of HPLC/GC column was used in the development and/or
validation of a particular test? Is there an alternative chromatographic column
for a particular test?
How can I obtain copies of monographs or general chapters proposed in
Pharmacopeial Forum, or monographs or general chapters that have appeared
in an edition of the USP-NF?
Could you provide copies of typical spectra (infrared and ultraviolet),
chromatograms, or validation data for monograph tests listed in the USP-NF?
Can you provide me with information on the clinical uses, adverse effects, and
other drug information for a particular drug or dietary supplement?
Does the USP have a list of dietary supplement companies claiming USP-NF on
their labels?
How do I convert the potency of a vitamin expressed in International Units (I.U.)
to (g or mg (and vice versa)?
How can I verify that the balances in our laboratory are suitable for weighing
the amounts specified in a USP monograph?
How does a plastic material receive a "Class VI" classification?
How are microbial limits and objectionable microorganisms determined?
Can I use an alternative, noncompendial analytical procedure for a test specified
in a USP-NF monograph to demonstrate compliance?
Do I have to perform all tests specified in a monograph to ensure compliance?
Do I have to use the quantities and concentrations specified in the monograph or
may I make some adjustments?
How do I contact the USP about questions on a specific monograph or general
chapter?
Do I have to meet the specifications described in the Description and Solubility
section of the USP-NF?
What is the status of my revision proposal? What is the status of the revision
proposal that appeared in Pharmacopeial Forum?
I would like to comment on a PF proposal but cannot do so during the
established public comment period. What can I do?
 Where can I find specifications for reagents? Who are the suppliers for a
particular reagent mentioned in a USP-NF monograph?
How do I find out if a particular Reference Standard is available?
What is the expiration date of a Reference Standard?
Can I obtain a Certificate of Analysis for a particular USP Reference Standard?
What is the "purity" of a USP Reference Standard where no percentage is stated
on the label?
What is the chemical name of a related compound specified in a test for
impurities in a monograph?
How do I propose new monographs and revisions to official standards in the
USP-NF or to revisions already proposed in Pharmacopeial Forum?
How do I inform USP that there may be an error in the text of the USP-NF or
proposed in Pharmacopeial Forum?
What is the total organic carbon (TOC) limit for Purified Water and Water for
Injection?
How often do I perform the TOC system suitability test?
Why are there no microbial requirements included in the monographs for
Purified Water and Water for Injection?

Q. What does compliance of a product with USP-NF standards entail?

A. An article of commerce complies with the USP-NF standards when an official
monograph exists for that article and the article meets all of the requirements stated in
the monograph. It must also comply with the requirements stated in the General
Notices section and all applicable General Chapters. NOTE-The requirements in the
monographs supercede those stated in the General Notices and General Chapters.
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Q. How much can I modify a chromatographic procedure and still be in
compliance? Can column length, internal diameter, mobile phase composition be
modified?
A. Yes, modifications can be made as long as the system suitability requirements for the
particular monograph test are met (see section Apparatus in the USP-NF General
Notices, and System Suitability under Chromatography <621>). A proposal on
modifications in a chromatographic method was published in Pharmacopeial Forum
27(5), page 3073, in the section System Suitability under Chromatography <621>.
This proposal is not official yet. It is still subject to public comments. Please see the
index of the most recent issue of Pharmacopeial Forum for possible updates of the
general chapter <621>.
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Q. What brand of HPLC/GC column was used in the development and/or
validation of a particular test? Is there an alternative chromatographic column
for a particular test?
A. The brand name of the column used in developing/validating a particular test or
alternative columns can be found in the USP publication "Chromatographic Reagents
Used in USP-NF and Pharmacopeial Forum", which is included in Internet USP-NF,
Version 2.0; print copies of this publication are available through Customer Services:
phone 301-881-0666, fax number 301-816-8148, e-mail custsvc@usp.org. For a
monograph published in Pharmacopeial Forum, this information is also available in
the last section of that Pharmacopeial Forum, Chromatographic Reagents Used in
USP-NF and Pharmacopeial Forum, and in the Briefing. If the test you are interested
in is not listed in the Chromatographic Reagents Used in USP-NF and
Pharmacopeial Forum, please send a message with the name of the monograph and
specific test of interest to stdsmonographs@usp.org.
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Q. How can I obtain copies of monographs or general chapters proposed in
Pharmacopeial Forum, or monographs or general chapters that have appeared
in an edition of the USP-NF?
A. Due to copyright requirements, single copies of monographs and general chapters
published either in USP-NF or in Pharmacopeial Forum can be obtained for a fee by
contacting the Secretary of the USP Convention (301-881-0666). Please note that for
compliance with current USP requirements for a particular article, one must comply
not only with the current monograph but also with all applicable General Chapters
and with the USP General Notices.
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Q. Could you provide copies of typical spectra (infrared and ultraviolet),
chromatograms, or validation data for monograph tests listed in the USP-NF?
A. Upon receipt of this type of request, the USP can provide such data only if it is
contained in USP files and it is not part of a confidential document. For more
information, the current USP Document Disclosure policy is printed within the USP-
NF.
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Q. Can you provide me with information on the clinical uses, adverse effects, and
other drug information for a particular drug or dietary supplement?
A. A multi-volume publication entitled USP DI? contains information on the use and
adverse effects of drugs and dietary supplements that is relevant to the physician,
pharmacist, the patient, and also information relevant to legal requirements.
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Q. Does the USP have a list of dietary supplement companies claiming USP-NF on
their labels?
A. No. Manufacturers of dietary supplements may use the letters USP or NF to indicate
 that a particular product meets the standards of the United States Pharmacopeia or
National Formulary, but the USP does not have a list of dietary supplement
companies claiming USP-NF on their labels.
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Q. How do I convert the potency of a vitamin expressed in International Units (I.U.)
to (?g or mg (and vice versa)?
A. The USP has discontinued the use of International Units and now specifies the
potency of vitamins in terms of metric mass units such as ?g or mg. The following
table shows the conversions.
Vitamin A, 1 I.U. = 0.3 ?g all-trans retinol
" 0.344 ?g all-trans retinyl acetate
" 0.55 ?g all-trans retinyl palmitate

Vitamin D, 1 I.U. = 0.025 ?g ergocalciferol or cholecalciferol

Vitamin E, 1 I.U. = 0.91 mg d,l-alpha tocopherol

" 1.0 mg d,l-alpha tocopheryl acetate
" 1.12 mg d,l-alpha tocopheryl acid succinate
" 0.67 mg d-alpha tocopherol
" 0.74 mg d-alpha tocopheryl acetate
" 0.83 mg d-alpha tocopheryl acid succinate

Beta carotene, 1 I.U. = 0.6 ?g of all-trans beta carotene

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Q. How can I verify that the balances in our laboratory are suitable for weighing
the amounts specified in a USP monograph?
A. Refer to general chapters Weights and Balances <41> and Weighing on an Analytical
Balance <1251> in the USP-NF. The procedure used to determine the suitability of
balances is indicated in Weights and Balances <41>. Note that under Weighing on an
Analytical Balance <1251>, it is stated that "...it is important for each balance to be
serviced and calibrated regularly by a specially trained internal or external service
person." Please check the index of the most recent issue of the Pharmacopeial Forum
for proposed updates of these general chapters.
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Q. How does a plastic material receive a "Class VI" classification?
A. The following is stated under general tests chapter Biological Reactivity Tests, In Vivo
<88>: "This classification is based on responses to a series of in vivo tests for which
extracts, materials, and routes of administration are specified." For example, for a
material to be classified as Class VI, the material would need to produce satisfactory
results for all of the tests listed in Table 1 of Biological Reactivity Tests, In Vivo <88>.
 back to top
Q. How are microbial limits and objectionable microorganisms determined?
A. In determining the appropriate microbial limit, the USP Analytical Microbiology
Expert Committee considers such matters as the route of administration, the form of
the product, and the source material. For example, it is never appropriate to have any
microorganisms in a product intended for injection intravenously. Therefore, you will
never see a microbial limit listed for such products. Instead, those products must meet
the test for Sterility <71>. Other products may be in a form possessing extremely low
water activity, such that microbial growth could not occur. You may not see microbial
limits provided for some of those products. Many other products, such as those
intended for oral administration, will have limits provided. Those limits are selected
such that the risk of harm to the consumer is extremely low, while being reasonable
from a manufacturing and quality control perspective. Products from botanical
sources may have higher limits due to the larger bioburden associated with the raw
materials. Again, the limits are set such that consumer risk is minimized without
creating an untenable situation for the manufacturer. Consideration is also given to
the likelihood of product spoilage. Since some products are more prone to spoilage
due to microbial contamination, limits may be set lower for these. The issues
discussed above also influence which, if any, specific organisms must be tested.
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Q. Can I use an alternative, noncompendial analytical procedure for a test specified
in a USP-NF monograph to demonstrate compliance?
A. Yes, you may use an alternative, validated method to demonstrate compliance with a
monograph. In the current USP-NF General Notices, the following is stated:
"Compliance may be determined also by the use of alternative methods, chosen for
advantages in accuracy, sensitivity, precision, selectivity or adaptability to automation
or computerized data reduction or in other special circumstances. Such alternative or
automated procedures shall be validated." However, there is a caveat to the use of
alternative methods. "Pharmacopeial standards and procedures are interrelated;
therefore, where a difference appears or in the event of a dispute, only the results
obtained by the procedure given in this Pharmacopeia is conclusive."
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Q. Do I have to perform all tests specified in a monograph to ensure compliance?
A. In the current USP-NF General Notices, it is stated: "Every compendial article in
commerce shall be so constituted that when examined in accordance with these assay
and test procedures, it meets all of the requirements in the monograph defining it.
However, it is not to be inferred that application of every analytical procedure in the
monograph to samples from every production batch is necessarily a prerequisite for
assuring compliance with Pharmacopeial standards before the batch is released for
distribution. Data derived from manufacturing process validation studies and from in-
process controls may provide greater assurance that a batch meets a particular
monograph requirement than analytical data derived from an examination of finished
 units drawn from that batch. On the basis of such assurances, the analytical
procedures in the monograph may be omitted by the manufacturer in judging
compliance of the batch with the pharmacopeial standards." However, the
performance of these procedures may be governed by laws or other requirements
related to good manufacturing practices which should be considered.
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Q. Do I have to use the quantities and concentrations specified in the monograph or
may I make some adjustments?
A. You may make some adjustments. In the current USP-NF General Notices, the
following is stated: "In the performance of assays and test procedures, not less than
the specified number of dosage units should be taken for analysis." Furthermore,
"[p]roportionately larger or smaller quantities than the specified weights and volumes
of assay or test substances and Reference Standards may be taken, provided the
measurement is made with at least equivalent accuracy and provided that any
subsequent steps, such as dilutions, are adjusted accordingly to yield concentrations
equivalent to those specified and are made in such a manner as to provide at least
equivalent accuracy."
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Q. How do I contact the USP about questions on a specific monograph or general
chapter?
A. The contact information for the USP staff can be found in a number of locations. The
staff members, their assignments, phone numbers and E-mail addresses are located in
the Staff Directory (one of the front sections of every Pharmacopeial Forum). In
addition, the names and contact information can be found in all electronic versions of
the USP-NF (CD-ROM, Intranet, and Internet). Finally, you can contact the USP
Headquarters at 301-881-0666 or stdsmonographs@usp.org . When calling this
number, please inform the operator that you would like to speak to someone in the
Information and Standards Development Department.
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Q. Do I have to meet the specifications described in the Description and Solubility
section of the USP-NF?
A. The specifications in the Description and Solubility section are not considered official
requirements by the USP. Within this section it states "The "description" and
"solubility" statements pertaining to an article (formerly included in the individual
monograph) are general in nature. The information is provided for those who use,
prepare, and dispense drugs, solely to indicate descriptive and solubility properties of
an article complying with monograph standards. The properties are not in themselves
standards or tests for purity even though they may indirectly assist in the preliminary
evaluation of the integrity of an article".
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Q. What is the status of my revision proposal? What is the status of the revision
proposal that appeared in Pharmacopeial Forum?
A. Contact the USP staff member responsible for the revision as indicated in
Pharmacopeial Forum. The staff members, their assignments, phone numbers and E-
mail addresses are located in the Staff Directory (one of the front sections of every
Pharmacopeial Forum). In addition, the names and contact information can be found
in all electronic versions of the USP-NF (CD-ROM, Intranet, and Internet).
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Q. I would like to comment on a PF proposal but cannot do so during the
established public comment period. What can I do?
A. In the back of every issue of Pharmacopeial Forum there is a form titled "Notice to
the Executive Secretariat of Intent to Comment". Complete the form and mail or fax
it to the USP immediately, and the appropriate USP Expert Committee will be
notified. The Expert Committee may or may not decide to extend the comment period
depending on the particular circumstances.
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Q. Where can I find specifications for reagents? Who are the suppliers for a
particular reagent mentioned in a USP-NF monograph?
A. The specifications for the reagents cited in USP-NF are generally found in the section
Reagents Specifications of the USP-NF. When there is only one supplier for a
particular reagent or a particular reagent grade, a footnote will cross-reference to the
supplier information in the section Reagent Footnotes of the USP-NF. If the reagent
you are interested in is not listed in the Reagents Specifications section, please
contact USP by email to stdsmonographs@usp.org.
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Q. How do I find out if a particular Reference Standard is available?
A. Check the USP Reference Standard Catalog in the latest issue of Pharmacopeial
Forum or on the USP Home Page: www.usp.org. If a particular USP Reference
Standard is not listed, it is not available.
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Q. What is the expiration date of a Reference Standard?
A. There are no predetermined expiration dates on USP Reference Standards. The
current lots of Reference Standards are official until otherwise stated in the USP
Reference Standard Catalog. The new lot is indicated in the column "Curr. Lot." The
column "Previous Lot/Valid Use Date" indicates the date on which the previous lot
will no longer be official.
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Q. Can I obtain a Certificate of Analysis for a particular USP Reference Standard?
A. Generally, no. Data on USP Reference Standards are not available for public
inspection, unless, in the judgment of the Secretary of the USP Convention a special
scientific reason exists. For more information, see the current USP Document
Disclosure Policy printed within the USP-NF.
 back to top
Q. What is the "purity" of a USP Reference Standard where no percentage is stated
on the label?
A. Where no value is stated on the label, the purity is considered to be 100.0% when
handled as described on the label.
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Q. What is the chemical name of a related compound specified in a test for
impurities in a monograph?
A. If there is a USP Reference Standard for the particular related compound, the
chemical name may be found in general chapter <11> USP Reference Standards in
the USP-NF. For methods proposed in Pharmacopeial Forum, this information is
included at the end of the monograph or in the general chapter USP Reference
Standards <11> in that PF.
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Q. How do I propose new monographs and revisions to official standards in the
USP-NF or to revisions already proposed in Pharmacopeial Forum?
A. Contact the USP in writing with any change you wish to make to the USP-NF. USP
contact information can be found in the front pages of the USP-NF or the Staff
Directory, printed in one of the front sections of every Pharmacopeial Forum. You
can also contact the USP Headquarters at 301-881-0666 or stdsmonographs@usp.org.
When calling this number, please inform the operator that you would like to speak to
someone in the Information and Standards Development Department. As described in
the USP general chapter Validation of Compendial Methods <1225>, all proposals
must be supported by relevant data including scientific rationale, complete analytical
procedures, and appropriate validation data. Revision proposals will be considered
only after receipt of supporting data and justification. Proprietary data should be
labeled "Confidential". All proposals approved by the USP Expert Committees are
published in the Pharmacopeial Forum for public comment, with the eventual goal of
official adoption in USP-NF.
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Q. How do I inform USP that there may be an error in the text of the USP-NF or
proposed in Pharmacopeial Forum?
A. Please contact the USP in writing or by email with the nature of the error found in
official text of the USP-NF or text proposed in Pharmacopeial Forum. USP contact
information can be found in the front pages of the USP-NF or the Staff Directory,
printed in one of the front sections of every Pharmacopeial Forum. You can also
contact the USP Headquarters at 301-881-0666 or stdsmonographs@usp.org . When
calling this number, please inform the operator that you would like to speak to
someone in the Information and Standards Development Department.
back to top
Q. What is the total organic carbon (TOC) limit for Purified Water and Water for
 Injection?
A. There is a "target limit response" of 500 ppb carbon. The actual number will vary
based upon your reference standard solution, your equipment, background carbon etc.
You will determine compliance using the USP Reference Standards.
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Q. How often do I perform the TOC system suitability test?
A. Most firms start by performing the test frequently; then after they have developed a
baseline, the testing schedule may be modified.
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Q. Why are there no microbial requirements included in the monographs for
Purified Water and Water for Injection?
A. Microbial guidelines are provided under Water for Pharmaceutical Purposes <1231>.
We recommend that you implement the Alert and Action levels and limits described
in this informational chapter.
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Not official USP-NF text

PACKING Octadecylsilane chemically bonded to porous silica or ceramic
micro-particles, 5 to 10 m in diameter.
L1 BRAND NAME MANUFACTURER
APEX ODS Jones Chromatography Inc.
AQUASIL C18 Therno Hypersil-Keystone
ASI C18 Analytical Sciences Inc.
ASI microC18 Analytical Sciences Inc.
Abzelute ODS-DB Metachem
Ace C18 Hichrom, Ltd.
Adsorbil C18 Alltech Associates
Adsorbosphere C18 Alltech Associates
Adsorbosphere HS C18 Alltech Associates
Not official USP-NF text
PACKING Octadecylsilane chemically bonded to porous silica or ceramic
micro-particles, 5 to 10 m in diameter.
L1 BRAND NAME MANUFACTURER
Adsorbosphere UHS C18 Alltech Associates
Adsorbosphere XL C18 Alltech Associates
Adsorbosphere XL300 C18 Alltech Associates
Allsphere ODS-1 Alltech Associates
Allsphere ODS-2 Alltech Associates
Alltech 600RP Alltech Associates
Alltech 600RP Alltech Associates
Alltech C18 Alltech Associates
Alltima C-18 Alltech, Inc.
Alltima C18 LL Alltech Associates
AlphaBond C18 Alltech Associates
Apex ODS Jones Chrom., Inc.
Aqua C18 Phenomenex
Aquapore OD-300 C18 PerkinElmer, Inc.
Aquasil C18 Thermo-Hypersil Keystone
Axxi-Chrom C18, ODS Axxiom
Bakerbond C18 JT Baker
BetaBasic 18 Thermo Hypersil-Keystone
Betasil C18 Thermo Hypersil-Keystone
Bio-Sil ODS BIO-RAD Laboratories
Bio-Sil ODS-10 BIO-RAD Laboratories
BioBasic 18 Keystone Scientific
Bondclone C18 Phenomenex
Brownlee RP-18 NULL
Burdick & Jackson C18 B&J
C-18 Ultrasphere Beckman Instruments, Inc.
C-18-IP Ultrasphere Beckman Instruments
Not official USP-NF text
PACKING Octadecylsilane chemically bonded to porous silica or ceramic
micro-particles, 5 to 10 m in diameter.
L1 BRAND NAME MANUFACTURER
CSC-S-ODS-2 NULL
CT-Sil-C18 NULL
Capcell AG C18 Shiseido
Capcell SG C18 Shiseido
Capcell SG C18 300A Shiseido
Capcell UG C18 Shiseido
Capcell UG C18 300A Shiseido
Capcell-pak SG 120 C18 Shiseido Co., Ltd.
Carbsorb ODS3 Metachem
Chemco Pak Chemcosorb ODS Dychrom
Chemcosorb 5-ODS-H Dychrom
Chromegabond C18 E.S. Industries
Chromegabond M-C18 E.S. Industries
Chromegabond WR-C18 ES Industries
Delta-Pak C18 Waters Associates
Delta-Pak HPI C18 Waters
Develosil ODS Nomura Chemical
Diazem 300 A C18 4-222 Diazem
Diazem 4-206 C18 Diazem
Diazem 4-230 C18 Diazem
Diazem 4-246 C18 Diazem
Diazem 4-247 C18EC Diazem
Diazem C18 Diazem
Diazem C18 1000 Diazem
Diazem C18 1120 Diazem
Diazem C18 120A Diazem
Diazem C18 120A series 43, Diazem
Not official USP-NF text
PACKING Octadecylsilane chemically bonded to porous silica or ceramic
micro-particles, 5 to 10 m in diameter.
L1 BRAND NAME MANUFACTURER
44, 45 and 46
Diazem C18 60A Diazem
Diazem C18 Dual-zone Diazem
Diazem C18 series 2000 Diazem
Diazem C18 series 200A, Diazem
300A
Diazem C18 series 3000 Diazem
Diazem C18 series EC Diazem
Discovery C18 Supelco Inc.
Eclipse XDB C18 Hewlett-Packard Co.
Econosil C18 Alltech Associates
Econosphere C18 Alltech Associates
Eurosphere 100 Saulentechnik
Fractogel TSK HW-40F MAC-MOD Analytical
Gammabond C18 NULL
Hi Chrom Reversible ODS Regis Inc.
Hibar II C18 EM Sciences
Hibar ODS EM Sciences
HydroBond PS-C18 MAC-MOD Analytical
Hyperprep 100 HS BDS C18 ThermoQuest
Chromatography
Hyperprep 120 C18 ThermoQuest
Chromatography
Hypersil BDS C-18 ThermoQuest
Chromatography
Hypersil C18 ThermoQuest
Chromatography
Hypersil Elite C18 ThermoQuest
Chromatography
Not official USP-NF text
PACKING Octadecylsilane chemically bonded to porous silica or ceramic
micro-particles, 5 to 10 m in diameter.
L1 BRAND NAME MANUFACTURER
Hypersil-ODS ThermoQuest
Chromatography
Hypersil-ODS NULL
IBM Octadecyl IBM Instruments Inc.
ISCO C-18 ISCO, Inc.
Inertsil 5 ODS-2 GL Sciences
Inertsil ODS-2 GL Sciences
Inertsil ODS-3 GL Sciences
J'Sphere ODS YMC Inc.
J'Sphere ODS-H80 YMC Inc.
J'Sphere ODS-M80 YMC Co., Ltd.
Knauer C-18 NULL
Kromasil C18 EKA Nobel
Kromasil KR 100 EKA Nobel
Kromasil ODS NULL
LiChrosorb RP-18 EM Sciences
LiChrosorb RP-Select B EM Sciences
LiChrosphere 100 RP-18 EM Sciences
Luna C18 Phenomenex
Maxsil C18 NULL
MetaCapsil C18 Metachem
MetaChem ODS Metachem
MetaPore C18 Metachem
MetaSil AQ Metachem
Metasil ODS Metachem
MicroBondapak C18 Waters Associates
MicroPak MCH-10 Varian
Not official USP-NF text
PACKING Octadecylsilane chemically bonded to porous silica or ceramic
micro-particles, 5 to 10 m in diameter.
L1 BRAND NAME MANUFACTURER
MicroPak MCH-5-N-Cap Varian Inc.
Microbondapak Radial-Pak Water Associates
Microsorb C18 Rainin Instrument Co., Inc.
Microsorb C18 ("Short-One") Rainin Instrument Co., Inc.
MonoChrom C18 Metachem
Nova-Pak C18 Waters Associates
Nova-Pak C18 Radial Pack Waters Associates
Cartridge
Nucleosil 10 C18 Macherey-Nagel
Nucleosil 5 C18 Macherey-Nagel
Nucleosil C18 Macherey-Nagel
Nucleosil C18 AB Macherey-Nagel
Nucleosil ODS Macherey-Nagel
Nucleosil RP18 Macherey-Nagel
ODS Ultrapak Beckman Instruments
PartiSphere C18 Whatman Inc.
PartiSphere RTF C18 Whatman Inc.
Partisil 10 ODS Whatman Inc.
Partisil 10 ODS-2 Whatman Inc.
Partisil 10 ODS-2 Whatman Inc.
Partisil 10 ODS-3 Whatman Inc.
Partisil 10 ODS-3 Whatman Inc.
Partisil 5 ODS-3 Whatman Inc.
Partisil 5 ODS-3 RAC II Whatman Inc.
Partisil ODS Whatman Inc.
Partisil ODS-1 Whatman Inc.
Partisil ODS-2 Whatman Inc.
Not official USP-NF text
PACKING Octadecylsilane chemically bonded to porous silica or ceramic
micro-particles, 5 to 10 m in diameter.
L1 BRAND NAME MANUFACTURER
Partisil ODS-3 Whatman Inc.
Peco HCODS Perkin-Elmer Corp.
Pecosil C18 Perkin-Elmer Corp.
Pecosphere 3x8C Perkin-Elmer Corp.
Pecosphere 3x8CR C18 Perkin-Elmer Corp.
Pecosphere 5x15CRT C18 Perkin-Elmer
Pecosphere-3C C18 Perkin-Elmer Corp.
Pecosphere-3CR C18 Perkin-Elmer Corp.
Pecosphere-3x3 C18 Perkin-Elmer Corp.
Peptica C18 Diazem
Pfarma C18 Diazem
Pinacle Ultra C18 Restek Corp.
Pinnacle ODS Restek Corp.
Platinum 300 C18 Alltech Associates
Platinum C18 Alltech Associates
Platinum EPS C18 Alltech Associates
Polaris C18-A Metachem
Polygosil 60-7 C18 Macherey-Nagel
Polygosil C18 Macherey-Nagel
Polygosil C18 60A Macherey-Nagel
PrimeSphere C18-HC Phenomenex
Prodigy ODS (3) Phenomenex
Purospher RP-18 Merck, KgaA
Purospher Start RP 18e MerckKGa
RP-18 Spheri-5 NULL
RSil C18 Alltech Associates
Radial Pak Resolve C18 Waters Associates
Not official USP-NF text
PACKING Octadecylsilane chemically bonded to porous silica or ceramic
micro-particles, 5 to 10 m in diameter.
L1 BRAND NAME MANUFACTURER
Radial-Pak C18 Waters Associates
Regis ODS Regis Instruments
Resolve C18 Waters Associates
Resolvex C18 Fisher Scientific
Spectraphysics C18 Spectra Physics Inc.
Spheri-10 RP-18 Applied Biosystems/Brownlee
Labs
Spheri-5 RP-18 Applied Biosystems Inc.
Spherisob ODS-2 Waters Associates
Spherisorb ODS Phase Separations Inc.
Spherisorb ODS1 Phase Separations Inc.
Spherisorb ODS2 Phase Separations Inc.
Spherisorb S10 ODS Phase Separations Inc.
Spherisorb S5 ODS Phase Separations Inc.
Supelcosil LC-18 Supelco, Inc.
Supelcosil LC-18-DB Supelco, Inc.
Supelguard LC18 Supelco Inc.
Superspher 100 RP-18 Merck KgaA
Symmetry C-18 NULL
Ultracarb Phenomenex
Ultracarb C18 Phenomenex
Ultracarb ODS (30) Phenomenex
Ultrasphere ODS Beckman Instruments
Velosep RP-18 Applied Biosystems Inc.
Versapack C18 Alltech Associates
Vydac 201TP Separations Group
Vydac 218TP54 Separations Group
Not official USP-NF text
PACKING Octadecylsilane chemically bonded to porous silica or ceramic
micro-particles, 5 to 10 m in diameter.
L1 BRAND NAME MANUFACTURER
Vydac C-18 Separations Group
Wakosil-II 5 C18-100 Wako
Waters Symmetry Waters Associates
Xterra MS C18 Waters Associates
YMC 18 ODS-A NULL
YMC A303-5 S-5 120A ODS YMC Inc.
YMC-AQ C18 YMC Co., Ltd.
YMC-Pack AQ-302 C18 YMC Co., Ltd.
YMC-Pack ODS-A YMC Inc.
YMC-Pack ODS-AM YMC Co. Ltd.
YMC-Pack ODS-AQ YMC Inc.
YMC-Pack Pro C18 YMC Inc.
YMCbasic NULL
Zorbax Eclipse XDB-C18 Agilent Technologies
Zorbax ODS Agilent Technologies
Zorbax Reliance ODS Agilent Technologies
Zorbax Rx-C18 Agilent Technologies
Zorbax SB-C18 Agilent Technologies

Not official USP-NF text

PACKING An essentially monomolecular layer of aminopropylsilane
chemically bonded to totally porous silica gel support 10 m
in diameter.
L8 BRAND NAME MANUFACTURER
Bond-Elute NH2 Analytichem International
Not official USP-NF text
PACKING An essentially monomolecular layer of aminopropylsilane
chemically bonded to totally porous silica gel support 10 m
in diameter.
L8 BRAND NAME MANUFACTURER
Carbohydrate Alltech Associates
Econosil Amino Alltech Associates
Econosphere Amino Alltech Associates
Hypersil APS-2 Thermo Hypersil Keystone
Hypersil-NH2 NULL
LiChrosorb NH2 EM Sciences
MicroBondapak NH2 Waters Associates
Nucleosil 10 NH2 Macherey-Nagel
RSiL NH2 Alltech Associates
Spherisorb NH2 Phase Separations Inc.
Zorbax NH2 MAC-MOD Analytical