1076308

Bleomycin sulfate

United States Pharmacopeia (USP) Reference Standard

• CAS Number: 9041-93-4
• MDL number: MFCD00070310
• UNSPSC Code: 41116107
• NACRES: NA.24

Properties

• grade: pharmaceutical primary standard
• API family: bleomycin
• form: lyophilized powder (; )
• manufacturer/tradename: USP
• application(s): pharmaceutical (small molecule)
• format: neat
• storage temp.: −20°C
• SMILES string: [S+](CCCNC(=O)c1nc([s]c1)c2nc([s]c2)CCNC(=O)C(NC(=O)C(C(O)C(NC(=O)C(NC(=O)c6nc(nc(c6C)N)C(NCC(N)C(=O)N)CC(=O)N)C(O[C@@H]4O[C@H]([C@H]([C@@H]([C@@H]4O[C@H]5O[C@@H]([C@H]([C@@H]([C@@H]5O)OC(=O)N)O)CO)O)O)CO)c3[nH]cnc3)C)C)C(O)C)(C)C.[S](=O)(=O)([O-])[O-].[H
• InChI: 1S/C55H83N17O21S3.H2O4S/c1-20-33(69-46(72-44(20)58)25(12-31(57)76)64-13-24(56)45(59)82)50(86)71-35(41(26-14-61-19-65-26)91-54-43(39(80)37(78)29(15-73)90-54)92-53-40(81)42(93-55(60)88)38(79)30(16-74)89-53)51(87)66-22(3)36(77)21(2)47(83)70-34(23(4)75)49(85)63-10-8-32-67-28(18-94-32)52-68-27(17-95-52)48(84)62-9-7-11-96(5)6;1-5(2,3)4/h14,17-19,21-25,29-30,34-43,53-54,64,73-75,77-81H,7-13,15-16,56H2,1-6H3,(H13-,57,58,59,60,61,62,63,65,66,69,70,71,72,76,82,83,84,85,86,87,88);(H2,1,2,3,4)/t21?,22?,23?,24?,25?,29-,30+,34?,35?,36?,37+,38+,39-,40-,41?,42-,43-,53+,54-;/m0./s1
• InChI key: WUIABRMSWOKTOF-OCBSMOPSSA-N

Description

General description

Bleomycin sulfate is a glycopeptide antibiotic with antitumor properties, acting through DNA strand scission. It is used in chemotherapy regimens for several cancers. The USP standard supports identity testing and potency assays in oncology-focused formulations.

The USP biologics antibiotics category includes a wide range of antimicrobial agents that are essential in treating bacterial infections. These antibiotics are derived from various natural sources or synthesized to combat specific pathogens effectively. The USP provides comprehensive standards, reference materials, and analytical procedures to ensure the identity, quality, purity, and consistency of antibiotic therapeutics throughout their lifecycle.

The United States Pharmacopeia (USP) provides quality standards for biologics to ensure their safety, efficacy, and quality throughout the manufacturing process. These standards assist manufacturers in adhering to regulatory requirements and help safeguard public health by reducing risks associated with biologics.

Application

Bleomycin sulfate USP reference standard, intended for use in specified quality tests and assays as specified in the USP compendia. Also, for use with USP monographs such as:

• Bleomycin for Injection

Analysis Note

These products are for test and assay use only. They are not meant for administration to humans or animals and cannot be used to diagnose, treat, or cure diseases of any kind.  ​

Other Notes

This product is part of the USP Biologics program.

This product is provided as delivered and specified by the issuing Pharmacopoeia. All information provided in support of this product, including SDS and any product information leaflets have been developed and issued under the Authority of the issuing Pharmacopoeia. For further information and support please go to the website of the issuing Pharmacopoeia. Bleomycin Sulfate is the sulfate salt of bleomycin, a combination of cytotoxic glycopeptides with a basic nature. It is either derived from the growth of Streptomyces verticillus or manufactured through alternative methods.

Sales restrictions may apply.

Safety Information

• pictograms: GHS08
• signalword: Danger
• hcodes: H340,H351,H361fd
• pcodes: P201 - P202 - P280 - P308 + P313 - P405 - P501
• Hazard Classifications: Carc. 2 - Muta. 1B - Repr. 2
• Storage Class: 6.1C - Combustible acute toxic Cat.3 / toxic compounds or compounds which causing chronic effects
• wgk_germany: WGK 3
• flash_point_f: Not applicable
• flash_point_c: Not applicable