Seractide Acetate API Manufacturer in India

Swapnroop Pharma · WHO-GMP Certified · +91 87670 62101

Seractide Acetate API Manufacturer in India

Seractide Acetate API is a peptide-based pharmaceutical active ingredient corresponding to a 39-amino-acid corticotropin-related peptide. It is the acetate salt of Seractide, a synthetic polypeptide related to human corticotropin and associated with adrenocorticotropic hormone (ACTH) receptor activity.

Seractide Acetate is identified in the FDA Substance Registration System under UNII DI9132OQ3R, with CAS Number 39295-97-1. A separate anhydrous acetate form is identified as CAS 39294-79-6 and UNII WVU0CZJ15L.

Seractide is a 39-amino-acid peptide. The peptide sequence associated with Seractide is:

SYSMEHFRWGKPVGKKRRPVKVYPNGAEDESAEAFPLEF

The parent Seractide has the molecular formula C₂₀₇H₃₀₈N₅₆O₅₈S and a reported molecular weight of approximately 4541 g/mol.

Swapnroop Drugs and Pharmaceuticals provides pharmaceutical API and peptide-product support with an emphasis on identity, analytical characterization, quality documentation and controlled pharmaceutical handling.

Seractide Acetate API Overview

Seractide Acetate belongs to the peptide/protein category and represents an acetate salt form of Seractide. The IUPHAR/BPS Guide to PHARMACOLOGY describes Seractide Acetate as the acetate salt of full-length 39-amino-acid human corticotropin-related material and identifies it as a peptide.

Seractide has activity associated with the melanocortin 2 receptor (MC2R), also known as the ACTH receptor. Through this receptor system, corticotropin-related peptides can stimulate adrenal cortical steroidogenesis.

Historical regulatory databases identify Seractide Acetate as a previously approved pharmaceutical substance. The available records indicate that the product is discontinued / no longer on the current FDA drug list, making accurate historical and regulatory positioning important when describing this material.

Chemical and Peptide Profile of Seractide Acetate

Unlike conventional small-molecule APIs, Seractide Acetate is a peptide salt. Its chemical identity is therefore best represented through its amino-acid sequence, salt form, peptide molecular characteristics and analytical identity rather than by relying only on conventional small-molecule descriptors.

Key Chemical Information

  • Product Name: Seractide Acetate
  • API Type: Peptide / Protein-related API
  • Compound Class: Peptide
  • Primary CAS Number: 39295-97-1
  • Anhydrous Acetate CAS: 39294-79-6
  • FDA UNII: DI9132OQ3R
  • Anhydrous UNII: WVU0CZJ15L
  • Parent Compound: Seractide
  • Parent CAS: 12279-41-3
  • Peptide Length: 39 amino acids
  • Parent Molecular Formula: C₂₀₇H₃₀₈N₅₆O₅₈S
  • Parent Molecular Weight: 4541 g/mol
  • Sequence: SYSMEHFRWGKPVGKKRRPVKVYPNGAEDESAEAFPLEF
  • Target: Melanocortin 2 receptor / ACTH receptor
  • Chemical Form: Acetate salt
  • Category: Peptide API

FDA GSRS identifies both hydrated and anhydrous Seractide Acetate forms separately, which is important when defining the exact material for procurement, specifications and analytical documentation.

Pharmaceutical and Biological Applications

Seractide is a corticotropin-related peptide associated with ACTH receptor activity. Historical pharmacological information describes Seractide as an MC2R agonist capable of stimulating adrenal cortical activity and increasing synthesis of corticosteroid hormones.

Historically, Seractide was investigated and approved in the United States in 1978. Available regulatory databases describe it as a previously marketed/approved substance and indicate that it was subsequently withdrawn and is not present on the current FDA drug list.

Potential pharmaceutical and research applications of Seractide Acetate may include:

  • Peptide pharmaceutical research
  • ACTH-related research
  • Corticotropin receptor studies
  • Adrenal-function research
  • Peptide analytical development
  • Pharmaceutical formulation research
  • Reference and comparative analytical studies
  • Historical pharmaceutical research

Any commercial pharmaceutical application should be assessed against the current regulatory status and applicable jurisdictional requirements.

Mechanism of Action

Seractide is associated with activity at the melanocortin 2 receptor (MC2R), the principal receptor through which ACTH stimulates the adrenal cortex.

Activation of this receptor can promote adrenal steroidogenesis, including production of glucocorticoids and other adrenal steroid hormones.

Because Seractide Acetate is a peptide related to corticotropin, its biological activity is fundamentally different from that of conventional small-molecule APIs. The biological identity and potency of peptide materials should therefore be evaluated using appropriate biochemical and analytical assays.

Seractide Acetate API Quality and Analytical Testing

Quality control of Seractide Acetate requires peptide-specific analytical characterization. A conventional small-molecule HPLC assay alone is generally insufficient to establish complete peptide identity and quality.

Depending on the applicable specification and intended use, analytical evaluation may include:

  • Appearance
  • Peptide identity
  • Amino-acid sequence confirmation
  • HPLC/UPLC purity
  • Related peptide impurities
  • Degradation products
  • Peptide content
  • Water content
  • Residual solvents
  • Counter-ion / acetate determination
  • Mass spectrometric identity
  • Microbial limits where applicable
  • Endotoxin testing where applicable
  • Bioburden where applicable
  • Potency / biological activity assay where required
  • Stability-indicating analysis

For peptide APIs, numerical acceptance criteria should be taken from the approved product specification or validated analytical procedure. Universal limits should not be invented.

Seractide Acetate API Manufacturer in India

Swapnroop Drugs and Pharmaceuticals supports pharmaceutical customers seeking peptide API and specialized pharmaceutical material solutions.

For Seractide Acetate, product quality should focus on accurate peptide identity, control of related peptide impurities, appropriate salt-form characterization, analytical purity, water content, microbial quality where applicable and suitable storage conditions.

Product documentation may be provided according to applicable customer and regulatory requirements, including:

  • Certificate of Analysis (CoA)
  • Product specification
  • Safety Data Sheet (SDS)
  • Analytical test reports
  • Peptide identity documentation
  • Chromatographic purity data
  • Mass spectrometry data where applicable
  • Packaging information
  • Storage and handling information
  • Stability information where applicable
  • Regulatory support documentation where applicable

Packaging and Storage of Seractide Acetate API

Seractide Acetate should be packaged in suitable pharmaceutical-grade containers that protect the peptide from moisture, light and environmental exposure as required by the validated storage specification.

Because peptides can be sensitive to temperature, moisture, oxidation and other environmental factors, the storage requirements should be based on validated stability data for the specific Seractide Acetate form.

The storage conditions of Seractide Acetate should therefore be established according to the manufacturer's approved specification rather than applying a generic temperature to every peptide product.

Documentation for Seractide Acetate API

Typical technical and quality documentation may include:

  1. Certificate of Analysis
  2. Product Specification
  3. Safety Data Sheet
  4. Batch Analytical Data
  5. Peptide Identity Data
  6. Chromatographic Purity Data
  7. Mass Spectrometry Data, where applicable
  8. Packaging Information
  9. Storage Conditions
  10. Stability Information, where applicable
  11. Regulatory Documentation, where applicable

Why Choose Seractide Acetate API from Swapnroop?

Swapnroop Drugs and Pharmaceuticals focuses on pharmaceutical API and specialized peptide-product requirements with attention to product identity, analytical characterization, quality documentation and controlled handling.

Key advantages include:

  • Pharmaceutical API-focused support
  • Peptide-specific analytical approach
  • Clear identification of Seractide Acetate salt form
  • CAS and regulatory identifier verification
  • Quality documentation support
  • Analytical characterization support
  • Controlled packaging and handling
  • Technical documentation
  • Support for pharmaceutical research and development requirements

For Seractide Acetate API requirements, contact Swapnroop Drugs and Pharmaceuticals for product specifications, analytical documentation, availability and commercial information.

Detailed Specifications

Parameter Specification
Appearance white to off-white crystalline powder
Identification IR & HPLC compliant
Assay (HPLC) 98.0% – 102.0%
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