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Deoxycholic Acid (DCA) API: Sourcing, Standards & Applications

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Deoxycholic acid (DCA) is the bile acid behind the first FDA-approved injectable fat-dissolution therapy — and it remains a niche, high-value API for formulators who understand its dual identity: a pharmaceutical active ingredient and a research-grade biochemical with detergent properties. This guide covers what buyers need to verify before sourcing DCA: monograph compliance (EP/USP), the bovine-bile supply chain, impurity profiles, and the documentation package that separates pharmaceutical-grade material from lab reagent.

1. What is Deoxycholic Acid?

Deoxycholic acid (DCA, CAS 83-44-3) is a secondary bile acid with the molecular formula C24H40O4 and a molecular weight of 392.57 g/mol. Unlike primary bile acids synthesized directly in the liver (cholic acid and chenodeoxycholic acid), DCA is formed in the intestine when gut bacteria dehydroxylate cholic acid at the 7-alpha position. This structural difference matters commercially: DCA is one of the more hydrophobic common bile acids, which gives it the detergent-like cell-disrupting properties that make it pharmaceutically useful.

Commercially, DCA is produced not by bacterial fermentation but by chemical reduction of cholic acid extracted from bovine bile. The starting material links DCA to the same supply chain as UDCA and CDCA — bile acid manufacturers who operate cholic acid extraction lines can produce all three from one upstream source. This is why China, with its integrated bovine-bile processing clusters, is the dominant global supplier of the entire bile acid API family.

2. Applications: Pharmaceutical and Beyond

DCA occupies an unusual position in the API market because demand splits across two distinct buyer groups:

  • Injectable fat-dissolution (pharmaceutical): DCA is the active ingredient in the first FDA-approved injectable treatment for submental (under-chin) fat reduction, approved in 2015. The mechanism relies on DCA's cytolytic effect — it physically disrupts adipocyte cell membranes when injected locally. Formulators working in this space require injectable-grade material with endotoxin control, far stricter than general chemical-grade DCA.
  • Research and biochemical (laboratory): DCA is a standard component of cell lysis buffers (RIPA buffer), bile salt media for microbiology (deoxycholate agar for enteric bacteria), and liposome preparation. Research buyers accept reagent grade but still need reproducible purity.
  • Synthesis intermediate: DCA serves as the starting material for deoxycholate salts (sodium deoxycholate, CAS 302-95-4) and for the synthesis of various bile acid derivatives used in drug delivery research.

3. Quality Standards: EP/USP Monographs and Injectable Grade

DCA is a pharmacopoeia-controlled substance with both EP and USP monographs. For API buyers, the critical distinction is the intended use, because the specification sets differ dramatically:

Key specification parameters
  • Assay: ≥99.0% by titration (typical HPLC purity 99.0-99.5% for pharma grade)
  • Related substances: cholic acid ≤0.5%, chenodeoxycholic acid ≤0.5%, total impurities ≤1.0%
  • Specific optical rotation: per EP/USP monograph (verifies stereochemical identity)
  • Residual solvents: ICH Q3C limits — methanol and ethyl acetate are the common residues from purification
  • Injectable-grade additions: bacterial endotoxins <0.5 EU/mg, bioburden and particulate specifications

Buyers sourcing DCA for an injectable product should demand the injectable-grade specification set up front — the gap between "EP-compliant chemical" and "injection-ready API" is significant, and qualifying a new grade later doubles your regulatory work.

4. Sourcing Deoxycholic Acid from China

China supplies the majority of the global bile acid API family, with production concentrated in Shandong and Henan provinces where bovine bile collection is integrated with the meat processing industry. When evaluating Chinese DCA suppliers, buyers should check the following:

  • Upstream integration: Does the supplier control cholic acid extraction, or do they buy intermediates? Integrated producers offer better batch consistency and traceability for the animal-origin raw material.
  • GMP status: DCA for pharmaceutical use must come from a GMP-certified facility. For injectable applications, expect questions about sterile filtration capability and endotoxin control.
  • TSE/BSE documentation: Because the raw material is bovine bile, regulators require a TSE/BSE risk assessment and statements of bovine origin for the bile source. A serious supplier provides this without being asked.
  • Batch traceability: Bile acid APIs should be traceable from the finished drum back to the bile collection batch. Audit the supplier's traceability system, not just their CoA.

Typical commercial terms: 1 kg trial quantities for method validation, 25 kg drums as the standard commercial package, and 4-8 week lead times for new production batches. For more on China API procurement generally, see our 6-step China sourcing guide.

5. KingWish Deoxycholic Acid Supply Capability

KingWish supplies the full bile acid family from our Shandong-based partner network — UDCA (our flagship, 40+ MT/year), CDCA, cholic acid, and deoxycholic acid — with shared documentation infrastructure: GMP certificates, batch CoAs with HPLC data, MSDS, TSE/BSE statements, and DMF/CEP support where applicable. Because we operate the same quality gates across the entire bile acid portfolio, buyers adding DCA to an existing UDCA program get consistent documentation and one point of contact.

For the full picture of the bile acid landscape, see our hepatology API guide and the UDCA vs CDCA comparison.

Standards: GMP Certified  |  FDA VMF 005884  |  CEP 2024-135-REV 00  |  Bile acid family supplier since 2006 CoA & TSE/BSE documentation available  |  August 2026

Related Resources

Quick Facts
CAS Number83-44-3
Molecular FormulaC24H40O4
Molecular Weight392.57 g/mol
PharmacopoeiaEP / USP
GradePharma (≥99%) / Injectable / Reagent
Packing25 KG/DRUM
MOQ1 KG (trial)