OLYMPUS CHEMICALS & FERTILIZERSIN BUSINESS FOR SCIENCE AND INNOVATION

MANUFACTURER OF PHARMACEUTICAL IMPURITY STANDARD & METABOLITE, CUSTOM SYNTHESIS

INTRODUCTIONOlympus 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 STRENGTHHighly 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 & FERTILIZERSIN BUSINESS FOR SCIENCE AND INNOVATION

MANUFACTURER OF PHARMACEUTICAL IMPURITY STANDARD & METABOLITE, CUSTOM SYNTHESIS

OUR FACILITIES -

Facilities for all kind of ORGANIC SYNTHESIS Facilities for analytical testing - Shimadzu LC solution HPLC, Shimadzu LC solution preparative HPLC, Lyophilizer, UV Spectrophotometer Shimadzu, Melting Point apertures, KF and other small instruments. Facilities of storage from Room temperature – freeze temperature to -20C is available. Facilities for Fast track currier services for domestic as well as abroad is available. Facilities of packing in high recovery vial for solid as well as liquid compound is available

OLYMPUS CHEMICALS & FERTILIZERSIN BUSINESS FOR SCIENCE AND INNOVATION

OUR SERVICES -

Our services to pharmaceuticals industries, formulation industries, chemicals industries, research institute, R&D labs, academic institution in India as well as abroad.

Our services in delivery of high quality products with certified COA and comprehensive analytical data.

Our services to provide complete technical support not only to our clients but to all. Our services to fast and promote reply to RFQ with best price and best timeline.

TIME TO TAKE A LOOK ON INVENTEORY

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

Products details click - https://www.olympusimpuritiesstandard.com/category/impurity-standard/

WE OFFER – WITH PRODUCTS

• Products with excellent packing and clear labeling• Certificate of analysis• HNMR with proper Interpretation• 13CNMR with proper Interpretation • Mass / LC_MS• HPLC (By pharmacopeia or In-house method)• IR• TGA• UVIf any more extra data we will be provide on request

OLYMPUS CHEMICALS & FERTILIZERSIN BUSINESS FOR SCIENCE AND INNOVATION

CERTIFICATE OF ANALYSISAZITHROMYCIN IMPURITY C

3′-O-DEMETHYLAZITHROMYCIN

Product Number No 11-OLY0020.03CAS Number: N.A. Long-term Storage: 2-8 0CLot Number: AZI-C-16 Appearance: Off White SolidMolecular Formula: C37H70N2O12 Melting Point: N.A.Molecular Weight: 734.98 g/mol Purity by HPLC: 94.01%Manufacturing date: September-28-2016Re-Test Date: September-28-2018This certificate is valid for two years from the date of shipmentProvided the substance is stored under the recommended conditions.

I. IDENTITYTHE IDENTITY OF THE REFERENCE SUBSTANCE WAS ESTABLISHED BY FOLLOWING ANALYSES.

IA. 1H-NMR SPECTRUMCONDITIONS: BRUKER 400 MHZ, DMSO-D6THE STRUCTURE IS CONFIRMED WITH THE SIGNALS OF THE SPECTRUM AND THEIR INTERPRETATION

IC. IR SPECTRUMMETHOD: ATTENUATED TOTAL REFLECTION FOURIER TRANSFORM INFRARED (ATR-FTIR) SPECTROSCOPY.INSTRUMENT: BRUKER MODEL ALPHA.

IB. MASS SPECTRUMMETHOD: AGILENT LC-, MODEL 1200 INFINITY SERIES: AGILENT MS, MODEL 6120

II. PURITYTHE PURITY OF THE REFERENCE SUBSTANCE WAS ANALYZED BY SHIMADZU SCL-10AVP HIGH PERFORMANCE LIQUID CHROMATOGRAPHY (HPLC).

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)

Diluent: 1.73g/l solution of ammonium dihydrogen phosphate adjusted pH 10.0 using ammonia, Transfer 350ml of this solution to suitable container. Add 300 ml of acetonitrile and 350 ml methanol. Mix well and sonicate.

Column: Conditions: Detector: Injector:

Gemini Gold (C18) 1.0 ml/min,210nm/UV Manual 5 μm, 150 x 4.6 mm 0-25 min A/B 50-55

50µl25-30 min A/B 55-6030-80 min A/B 60-7580-92 min A/B 75-50

(v/v)

Relative Retention Time (RRT) Calculation – Retention Time of Impurity (RT)/Retention (RT) Time of API. (44.660/60.378 = 0.73)

Results:Purity: 94.01 %Method: Azithromycin USPAPI RT: 60.378Observed RRT: 0.73Reported RRT: 0.73

Method: TGA Thermograms, The Percent of weight loss at 30-1200C is 3.862%

III. Water Content

REVIEWED BY

HEAD OF QA & QC

APPROVED BY

MANAGENING DIRECTOR

IV. Residual SolventsMethod: 1H-NMRNo significant amounts of residual solvents were detected (< 0.05 %).V. Potency%Potency = (Chromatographic purity – TGA Value) = (94.01-3.862) = 90.14%VI. Final ResultTotal impurities (HPLC) 5.983 %Water Content: 3.862%Purity by HPLC: 94.01Residual solvents: < 0.05 %Potency: 90.14%Release Date: 2016-10-10 

OLYMPUS CHEMICALS & FERTILIZERSIN BUSINESS FOR SCIENCE AND INNOVATION

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