1 / 13

API, Pharmacopoeia Impurities | Olympus Impurities Standard Suppliers

Olympus Chemical & Fertilizers is professional impurity manufacturer and supplier of all Impurities Standards and there products. We provide you with wide variety of products of impurities.<br>Visit @ https://www.olympusimpuritiesstandard.com/<br>

olympuschemicalsfertilizers
Download Presentation

API, Pharmacopoeia Impurities | Olympus Impurities Standard Suppliers

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Olympus chemicals & fertilizersIn Business for science and innovation Manufacturer Of pharmaceutical impurity standard & metabolite, custom synthesis 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.

  2. 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

  3. 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.

  4. 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/

  5. Olympus chemicals & fertilizersIn Business for science and innovation 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 • UV • If any more extra data we will be provide on request

  6. Certificate of AnalysisAzithromycin Impurity C 3′-O-DEMETHYLAZITHROMYCIN Product Number No 11-OLY0020.03 CAS Number: N.A. Long-term Storage: 2-8 0C Lot Number: AZI-C-16 Appearance: Off White Solid Molecular Formula: C37H70N2O12 Melting Point: N.A. Molecular Weight: 734.98 g/mol Purity by HPLC: 94.01% Manufacturing date: September-28-2016 Re-Test Date: September-28-2018 This certificate is valid for two years from the date of shipment Provided the substance is stored under the recommended conditions.

  7. 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

  8. 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

  9. 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 50µl 25-30 min A/B 55-60 30-80 min A/B 60-75 80-92 min A/B 75-50 (v/v)

  10. 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 USP API RT: 60.378 Observed RRT: 0.73 Reported RRT: 0.73

  11. III. Water Content Method: TGA Thermograms, The Percent of weight loss at 30-1200C is 3.862%

  12. 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 Reviewed By Head Of QA & QC APPROVED BY MANAGENING DIRECTOR

  13. Olympus chemicals & fertilizersIn Business for science and innovation Thank You !

More Related