Professional Documents
Culture Documents
INTRODUCTION
Olympus Chemical & fertilizers is India based company doing business in manufacturing and
supply of certified pharmacopeia impurities, process impurities, metabolites, degradation
impurities and custom synthesis services.
Our ability to deliver high quality services and solutions to pharmaceutical industry in India as
well as abroad
OUR STRENGTH
Highly qualified staff of scientist and chemist.
Quality & Trust are the two hands of our business.
Effective communication with clients.
Focus on timely delivery of products & caring about clients timeline.
Always believe in team work and strong association.
OLYMPUS CHEMICALS & FERTILIZERS
IN BUSINESS FOR SCIENCE AND INNOVATION
OUR FACILITIES -
OUR SERVICES -
OLYMPUS INVENTEORY SYSTEM (OIS) < 1000 IMPURITIES IN STOCK, 5-8 ADDED EVERY MONTH
AZITHROMYCIN IMPURITIES CYCLOSERINE IMPURITIES MONTULUKAST IMPURITIES
ACYCLOVIR IMPURITIES DAREFENACIN IMPURITIES QUETIAPINE IMPURITIES
AMBROXOL IMPURITIES DRONEDARON IMPURITIES RASAGALINE IMPURITIES
ARRIPIPRAZOLE IMPURITIES DEXMEDITOMDINE IMPURITIES ROPINIROL IMPURITIES
BUSPIRONE IMPURITIES GABAPENTENE IMPURITIES SOLIFINACIN IMPURITIES
CANDESARTAN IMPURITIES HYDROCORTISONE IMPURITIES TELMISARTAN IMPURITIES
CARVEDILOL IMPURITIES LEVOTHYROXINE IMPURITIES TRAZADONE IMPURITIES
CINACALCET IMPURITIES LORATIDINE IMPURITIES
HPLC Conditions:
Solution A: 1.80 g/l solution of disodium hydrogen phosphate, pH
adjusted to 8.9 using dilute phosphoric acid or dilute sodium hydroxide.
Solution B: Methanol: Acetonitrile (250:750 V/V)
Results:
Purity: 94.01 %
Method: Azithromycin USP
API RT: 60.378
Observed RRT: 0.73
Reported RRT: 0.73
III. Water Content
Method: TGA
Thermograms, The
Percent of weight loss at
30-1200C is 3.862%
IV. Residual Solvents
Method: 1H-NMR
No significant amounts of residual solvents were detected (< 0.05 %).
V. Potency
%Potency = (Chromatographic purity TGA Value) = (94.01-3.862) = 90.14%
VI. Final Result
Total impurities (HPLC) 5.983 %
Water Content: 3.862%
Purity by HPLC: 94.01
Residual solvents: < 0.05 %
Potency: 90.14%
Release Date: 2016-10-10
APPROVED BY
REVIEWED BY
Thank You !