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PHR8659

Teriparatide

certified reference material, pharmaceutical secondary standard

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Synonym(s):
Parathyroid Hormone Fragment 1-34 human, PTH 1-34, Parathormone (1-34)
Empirical Formula (Hill Notation):
C181H291N55O51S2
CAS Number:
Molecular Weight:
4117.72
MDL number:

grade

certified reference material
pharmaceutical secondary standard

Quality Level

agency

traceable to EP Y0001916
traceable to USP 1643962

API family

teriparatide

packaging

pkg of 1MG

application(s)

pharmaceutical

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

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Amino Acid Sequence

Ser-Val-Ser-Glu-Ile-Gln-Leu-Met-His-Asn-Leu-Gly-Lys-His-Leu-Asn-Ser-Met-Glu-Arg-Val-Glu-Trp-Leu-Arg-Lys-Lys-Leu-Gln-Asp-Val-His-Asn-Phe

General description

Teriparatide, a pharmaceutical secondary standard, is a recombinant fragment of human parathyroid hormone. The therapeutic is a potent osteoanabolic agent. It consists of the first 34 aminoacids of the hormone′s N-terminal region. Teriparatide is an analog of parathyroid hormone. It binds to the parathyroid hormone (PTH) type 1 receptor using its N-terminal portion.

Application

The teriparatide pharmaceutical secondary standard is a certified reference material (CRM) that includes a comprehensive Certificate of Analysis (COA). This new product also includes the added value of traceability to the current USP and EP primary reference standard batch. Pharmaceutical secondary standards for application in quality control provide pharma laboratories and manufacturers with a convenient and cost-effective alternative to the preparation of in-house working standards.

Biochem/physiol Actions

Teriparatide exhibits similar effects to endogenous parathyroid hormone (PTH), regulating calcium and phosphate levels by increasing serum calcium and decreasing serum phosphate. These effects primarily occur through the well-established effects of PTH on the kidneys and bone. Teriparatide acts as an effective agent in managing osteoporosis. In addition to its therapeutic benefits, teriparatide also carries a theoretical risk of osteosarcoma as a potential side effect.

Other Notes

This secondary biopharma certified reference material (CRM) is produced and certified in accordance with ISO 17034 and ISO/IEC 17025. All information regarding the use of this CRM can be found on the certificate of analysis. These secondary standards offer multi-traceability to the USP, EP, and BP primary standards, where they are available.

Storage Class

11 - Combustible Solids

wgk_germany

WGK 3

flash_point_f

Not applicable

flash_point_c

Not applicable


Certificates of Analysis (COA)

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Teriparatide
Vall H and Parmar M.
StatPearls [Internet] (2023)

Articles

This application note describes a step-by-step LC-UV-MS workflow for teriparatide peptide mapping, that includes enzymatic digestion, separation conditions, and their high resolution QTOF mass spectrometer based identification.

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