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1643962

USP

Teriparatide

Name: Teriparatide
Brand: USP

United States Pharmacopeia (USP) Reference Standard

Synonym(s):

Parathyroid Hormone Fragment 1-34 human, PTH 1-34, Parathormone (1-34)

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About This Item

Empirical Formula (Hill Notation):

C₁₈₁H₂₉₁N₅₅O₅₁S₂

CAS Number:

52232-67-4

Molecular Weight:

4117.72

UNSPSC Code:

41116107

NACRES:

NA.24

MDL number:

MFCD00149013

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Properties

grade

pharmaceutical primary standard

agency

USP

API family

teriparatide

manufacturer/tradename

USP

application(s)

USP Biologics
pharmaceutical (small molecule)

format

neat

storage temp.

−20°C

SMILES string

S(CC[C@H](NC(=O)[C@@H](NC(=O)[C@@H](NC(=O)[C@@H](NC(=O)[C@@H](NC(=O)[C@@H](NC(=O)CNC(=O)[C@@H](NC(=O)[C@@H](NC(=O)[C@@H](NC(=O)[C@@H](NC(=O)[C@@H](NC(=O)[C@@H](NC(=O)[C@@H](NC(=O)[C@@H](NC(=O)[C@@H](NC(=O)[C@@H](NC(=O)[C@@H](N)CO)C(C)C)CO)CCC(=O)O)[C@H](C

InChI

1S/C181H291N55O51S2.C2H4O2/c1-21-96(18)146(236-160(267)114(48-53-141(250)251)212-174(281)132(84-239)232-177(284)143(93(12)13)233-147(254)103(185)82-237)178(285)216-111(45-50-134(187)241)155(262)219-119(65-90(6)7)163(270)213-116(55-62-289-20)158(265)224-124(71-100-79-196-86-203-100)167(274)226-126(73-135(188)242)169(276)217-117(63-88(2)3)148(255)201-81-138(245)205-105(39-27-30-56-182)149(256)223-123(70-99-78-195-85-202-99)166(273)221-121(67-92(10)11)164(271)225-128(75-137(190)244)171(278)231-131(83-238)173(280)214-115(54-61-288-19)157(264)210-112(46-51-139(246)247)153(260)208-109(43-34-60-199-181(193)194)159(266)234-144(94(14)15)175(282)215-113(47-52-140(248)249)156(263)222-122(69-98-77-200-104-38-26-25-37-102(98)104)165(272)220-120(66-91(8)9)161(268)209-108(42-33-59-198-180(191)192)151(258)206-106(40-28-31-57-183)150(257)207-107(41-29-32-58-184)152(259)218-118(64-89(4)5)162(269)211-110(44-49-133(186)240)154(261)228-129(76-142(252)253)172(279)235-145(95(16)17)176(283)229-125(72-101-80-197-87-204-101)168(275)227-127(74-136(189)243)170(277)230-130(179(286)287)68-97-35-23-22-24-36-97;1-2(3)4/h22-26,35-38,77-80,85-96,103,105-132,143-146,200,237-239H,21,27-34,39-76,81-84,182-185H2,1-20H3,(H2,186,240)(H2,187,241)(H2,188,242)(H2,189,243)(H2,190,244)(H,195,202)(H,196,203)(H,197,204)(H,201,255)(H,205,245)(H,206,258)(H,207,257)(H,208,260)(H,209,268)(H,210,264)(H,211,269)(H,212,281)(H,213,270)(H,214,280)(H,215,282)(H,216,285)(H,217,276)(H,218,259)(H,219,262)(H,220,272)(H,221,273)(H,222,263)(H,223,256)(H,224,265)(H,225,271)(H,226,274)(H,227,275)(H,228,261)(H,229,283)(H,230,277)(H,231,278)(H,232,284)(H,233,254)(H,234,266)(H,235,279)(H,236,267)(H,246,247)(H,248,249)(H,250,251)(H,252,253)(H,286,287)(H4,191,192,198)(H4,193,194,199);1H3,(H,3,4)/t96-,103-,105-,106-,107-,108-,109-,110-,111-,112-,113-,114-,115-,116-,117-,118-,119-,120-,121-,122-,123-,124-,125-,126-,127-,128-,129-,130-,131-,132-,143-,144-,145-,146-;/m0./s1

InChI key

BUUKFBVDKSFMHN-LKMAISLMSA-N

Description

General description

Teriparatide, also known as rhPTH (1-34), is a recombinant peptide consisting of the first 34 amino acids of human parathyroid hormone. It is produced using recombinant DNA technology in bacterial expression systems. The USP standard supports structural and biological activity analysis for osteoporosis-related therapies.

The USP biologics peptides category encompasses a diverse range of therapeutic peptides that are essential in managing various medical conditions. These peptides, typically consisting of amino acid sequences of 40 residues or less, are critical for the development of high-quality medicines. The USP provides comprehensive standards, reference materials, and analytical procedures to ensure the identity, quality, purity, and consistency of peptide 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

Teriparatide USP reference standard is intended to be used in specified quality tests and assays. It is also used in the preparation of standards solutions for the peptide mapping and bioidentity procedures during the identification and assay of teriparatide and teriparatide injection using liquid chromatography (LC) coupled to UV detector at 214 nm as described in the United States Pharmacopeia (USP) monographs. Based directly on official monographs published in the USP-NF, these highly characterized physical specimens are used in testing by pharmaceutical and related industries to help ensure the identity, strength, quality and purity of peptide-based medicines.
Further information is available in the monograph, Teriparatide, USPNF 2021 ISSUE 3 of the USP (United States Pharmacopeia).

Other Notes

Sales restrictions may apply.

This product is part of the USP Biologics program.

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Storage Class

11 - Combustible Solids

wgk

WGK 3

flash_point_f

Not applicable

flash_point_c