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Buprenorphine Hydrochloride Usp Ip Ep Bp Manufacturer - India

price: contact company for price

CERTIFICATE OF ANALYSIS

Product Name Buprenorphine Hydrochloride USP CAS No:

Batch No: BUP/ 030313 A. R. No 13/ FP/ BUP/ 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 chloride test: The sample solution meets the requirements.

4. Related Substances

Individual Impurity Total Impurity

0.11 %

0.29%

NMT 0.25%

NMT 0.65%

5. Specific Optical Rotation at 20 0 C ( Anhydrous Basis) - 94º Between - 92° to - 98°

6. pH in a solution containing 10 mg/ mL 5.3 Between 4.0- 6.0

7. Water Content by KF 0.6% NMT 1.0%

11. Residue On Ignition 0.03% NMT 0.1%

12. Assay HPLC 99.37% 98.5 to 101.0%

. .

Buprenorphine

Skeletal formula of buprenorphine

Ball- and- stick model of the buprenorphine molecule

Systematic ( IUPAC) name

( 2S) - 2- [ ( 5R, 6R, 7R, 14S) - 9α - cyclopropylmethyl- 4, 5- epoxy- 6, 14- ethano- 3- hydroxy- 6- methoxymorphinan- 7- yl] - 3, 3- dimethylbutan- 2- ol

Clinical data

Trade names Buprenex, Subutex, Suboxone, Butrans, Cizdol

AHFS/ Drugs. com monograph

MedlinePlus a605002

Pregnancy

category

AU: C

US: C ( Risk not ruled out)

Legal status

AU: Controlled ( S8)

CA: Schedule I

UK: Class C

US: Schedule III

Routes of

administration sublingual, IM, IV, transdermal, intranasal, rectally, orally.

Pharmacokinetic data

Bioavailability 30% ( sublingual) [ 1] / 48.2±8.35% ( intranasal) [ 2]

Protein binding 96%

Metabolism hepatic

CYP3A4, CYP2C8

Biological half- life 20–70, mean 37 hours

Excretion biliary and renal

Identifiers

CAS Registry Number 52485- 79- 7 Yes

ATC code N02AE01 N07BC01

PubChem CID: 644073

IUPHAR/ BPS 1670

DrugBank DB00921 Yes

ChemSpider 559124 Yes

UNII 40D3SCR4GZ Yes

KEGG D07132 Yes

ChEBI CHEBI: 3216 Yes

ChEMBL CHEMBL1201894

Chemical data

Formula C29H41NO4

Molecular mass 467.64 g/ mol


Company Contact:


  • Phone: 912406641875

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

  • Email: Email


Published date: September 5, 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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