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Sufentanil Citrate Usp Ip Bp Ep Manufacturer - India

price: contact company for price

CERTIFICATE OF ANALYSIS

Product Name Sufentanil Citrate USP CAS No: 60561- 17- 3

Batch No: SUF/ 030313 A. R. No 13/ FP/ SUF/ 0303

Date of Manufacture Feb- 2013 Date of Analysis 02- 02- 13

Batch Quantity 165 kg Date of Retest Jan- 2016

Sr. No Test Results Acceptance Criteria

1. Appearance

2. Solubility

3. Identification

Complies a) By IR Spectrum: The infrared absorption spectrum of the test sample exhibits maxima only at the same wavelengths as that of the working standard.

Complies b) By HPLC: Retention time of the principle peak in the chromatogram obtained with sample solution should match with that of the principle peak in chromatogram obtained with standard solution.

Complies c) Citrate: The aqueous layer meets the requirements.

4. Related Substances

Individual Impurity Total Impurity

0.18%

0.72%

NMT 0.5%

NMT 1.0%

5. Loss on drying 0.27% NMT 0.5%

6. Heavy Metals Complies NMT 20ppm

7. Assay HPLC 99.38% 98.0% –101.0%

Sufentanil

Sufentanil. svg

Sufentanil- xtal- 3D- balls- A. png

Systematic ( IUPAC) name

N- [ 4- ( methoxymethyl) - 1- ( 2- thiofuran- 2- ylethyl) - 4- piperidyl] - N- phenylpropanamide

Clinical data

Trade names Sufenta

AHFS/ Drugs. com monograph

Pregnancy

category

US: C ( Risk not ruled out)

Legal status

AU: Controlled ( S8)

UK: Class A

US: Schedule II

℞ ( Prescription only)

Routes of

administration IV, IM, SubQ, epidural, intrathecal, transdermal patch ( in clinical trials)

Pharmacokinetic data

Biological half- life 162 minutes

Duration of action 30 to 60 min[ 1]

Identifiers

CAS Registry Number 56030- 54- 7 Yes

ATC code N01AH03

PubChem CID: 41693

IUPHAR/ BPS 3534

DrugBank DB00708 Yes

ChemSpider 38043 Yes

UNII AFE2YW0IIZ Yes

KEGG D05938 Yes

ChEBI CHEBI: 9316 Yes

ChEMBL CHEMBL658 Yes

Chemical data

Formula C22H30N2O2S

Molecular mass 386.552 g/ mol

SMILES


Company Contact:


  • Phone: 912406641875

  • Address: PLOT NO: 04 JALGAON ROAD, HARSOOL, AURANGABAD, India

  • Email: Email


Published date: September 14, 2015 -

  • Business Description: We, at SWAPNROOP, are committed to providing affordable Drugs &

    Pharmaceuticals of global quality standards to Pharma Companies all over

    the world. In our warehouse facilities, approved by FDA. we supply

    Pharmaceutical Finished products, Dental products and Active

    Pharmaceutical Ingredients.

    We, at SWAPNROOP, are committed to providing affordable Drugs & Pharmaceuticals of global quality standards to Pharma Companies all over the world. Our warehouse facilities is approved by FDA and we are specializes in sales and marketing of Pharmaceutical Finished products, Pharmaceutical Active Ingredients (API's) and Dental products, providing a wide range of quality and affordable products to a large number of pharmaceutical companies, reputed private and government/semi government organizations/ research centers as well as universities.

    We supply and market over 500 molecules and their combinations in multiple dosage forms, catering to patient needs in various therapies. These include Anti infectives, Cardiovascular, Pain management, Central Nervous System (CNS), Gastrointestinal, Respiratory, Dermatology, Orthopaedics, Nutritionals, Urology and Dental.

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