pTH (1-34) (human) Acetate

cmc development

Teriparatide / pTH (1-34) (human) Acetate

H-4835-GMP, 4158068

Regulatory Documentation

DMF

CAS-Number

52232-67-4 (net), 99294-94-7 (acetate)

Synonyms

Parathyroid hormone (1-34) (human)

Sequence

H-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-OH acetate salt

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Teriparatide is the API to treat osteoporosis


Teriparatide is derived from the human parathyroid hormone

Teriparatide, an active pharmaceutical ingredient (API), is a fragment of the human parathyroid hormone (PTH), which plays a crucial role in regulating calcium levels, bone remodelling, and kidney functions. The parathyroid hormone (PTH) is a polypeptide containing 84 amino acids, produced by the parathyroid glands located near the thyroid gland in the neck. When calcium levels in the blood decrease, PTH is secreted, initiating the breakdown of bone tissue to release calcium. This hormone not only facilitates the reabsorption of calcium in the kidneys but also activates the conversion of vitamin D into calcitriol, enhancing calcium absorption from the intestines. Teriparatide replicates the 34 N-terminal amino acids of PTH, embodying its potent bone-forming capabilities. 

Teriparatide stimulates bone formation

Both the full-length PTH and its fragment, Teriparatide (PTH 1-34), play a dual role in bone metabolism–both resorbing and forming bone. The balance between these actions is key in managing serum calcium levels. Continuous exposure to high levels of PTH can result in excessive calcium release from bones, leading to osteoporosis. However, Teriparatide, when used therapeutically, is administered intermittently, mimicking the natural pulsatile release of PTH. This mode of administration works to encourage osteoblast (bone-building cells) activity, helping bone formation and offering a therapeutic way of treating osteoporosis. By doing it this way Teriparatide not only mitigates the risk of osteoporosis but actively reverses its course by enhancing bone formation and increasing bone mass strength. This therapeutic approach provides a significant benefit in the treatment and management of osteoporosis, offering a targeted strategy to improve bone health and patient outcomes. 

Teriparatide can be manufactured by solid phase peptide synthesis

Initially approved in the United States in 1987 as a diagnostic agent for parathyroid conditions and later in 2002 with the FDA approval for the treatment of osteoporosis in men and postmenopausal women who are at high risk of having a fracture. Teriparatide was originally produced recombinantly, but its synthetic version, called pTH(1-34) has been synthesised using the sophisticated technique of solid-phases peptide synthesis (SPPS). SPPS is renowned for its ability to assemble peptides with high precision, which is critical for producing peptides like Teriparatide with the required specificity and activity. This method involves the sequential addition of protected amino acid residues to a growing peptide chain, which allows for the creation of exact peptide sequences necessary for biological activity. Bachem, a leader in peptide synthesis, has established itself as a trusted partner with over five decades of experience in peptide chemistry, pioneering advancements in this field, to ensure that our GMP-grade peptides meet the stringent standards and regulatory requirements of quality and efficacy. 

Choose secure supply from the market leader Bachem

Selecting Bachem for your Teriparatide API needs provides access to a leading peptide technology expert with an established excellence record. Our cutting-edge manufacturing capabilities ensure a high yield and consistent quality across batches, maintaining a reliable supply chain. With a commitment to the highest quality and compliance standards, Bachem offers GMP-certified Teriparatide and extensive regulatory support. Choose Bachem for effortless procurement, backed by streamlined customer service and adaptable order sizes.

Bachem’s services are tailored to prioritize timely delivery, regulatory compliance and exceptional quality – key factors for your success. We support our clients with rapid shipping, facilitated by our ample inventory and the efficient handling of regulatory documentation, including Drug Master Files and European Pharmacopoeia Certificates. Plus, our meticulous impurity management ensures the integrity and safety of our products.

At Bachem, our commitment to excellence ensures that our clients receive only the best, most reliable products swiftly and efficiently.

 

Related generic APIs and services

At Bachem we offer a diverse array of peptides similar to Teriparatide, available for both research and clinical applications. Our products related to Teriparatide, showcasing our capabilities in peptide synthesis and modification are available on the online shop.

 

Fields of Application

Osteoporosis – not yet an approved application
Diagnosis of hypoparathyroidism

Active Substance

pTH (1-34) (human) corresponds to N-terminal part of human parathyroid hormone, a peptide consisting of 84 amino acids. pTH (1-34) (human) shows the same activity and pharmacological profile as the native peptide hormone.
Intermittent administration of pTH (1-34) (human) acetate in low dosage stimulates bone formation and increases bone mineral density.
Bachem’s pTH (1-34) (human) is obtained by chemical synthesis.

Molecular Information

Molecular Formula

C181H291N55O51S2

Relative Molecular Mass

4117.77 g/mol

Long-term Storage

-20 ± 5°C

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