Nutraceutical

S-Adenosyl-L-Methionine (SAMe) Manufacturer & Supplier in India | MEDIOCON INC

CAS: 485-80-3 Nutraceutical Nutraceutical GMP Certified Aurangabad, Maharashtra, India
S-Adenosyl-L-Methionine (SAMe) Manufacturer & Supplier in India | MEDIOCON INC — Mediocon Inc
S-Adenosyl-L-Methionine (SAMe) Manufacturer & Supplier in India | MEDIOCON INC

Product Overview

CAS No: 485-80-3 | Grade: Nutraceutical | Category: Nutraceutical

S-Adenosyl-L-Methionine (SAMe) as Health Supplement

S-Adenosyl-L-Methionine (SAMe) is a naturally occurring sulfur-containing compound involved in important biochemical methylation processes in the human body. It is formed naturally from L-methionine and ATP and functions as a methyl-group donor in numerous enzymatic reactions. SAMe is also known as S-adenosylmethionine or ademetionine and is commercially available as a nutraceutical ingredient and health-supplement raw material. PubChem identifies S-adenosyl-L-methionine as a naturally occurring metabolite and cofactor involved in biological processes.

MEDIOCON INC supplies S-Adenosyl-L-Methionine (SAMe) for health-supplement and nutraceutical applications. Commercial SAMe raw material is commonly supplied in stabilized salt forms, particularly S-Adenosyl-L-Methionine Disulfate Tosylate, because the salt form provides a practical form for manufacturing and quality control. A documented food-use specification identifies SAMe disulfate tosylate as a nutritional ingredient and specifies a white to off-white powder with assay requirements of 95.0–105% for S-Adenosyl-L-Methionine disulfate tosylate.

SAMe participates in biological methylation reactions and is involved in the metabolism of methionine and other cellular compounds. Because SAMe is chemically sensitive and can occur in different salt forms, manufacturers should clearly identify the supplied form on the product specification and Certificate of Analysis. Analytical testing of SAMe in dietary supplements can be performed using reversed-phase HPLC, with published methods demonstrating suitable quantitative analysis of SAMe in commercial health products.

For commercial nutraceutical applications, quality control of SAMe includes identification, assay, stereoisomer composition, moisture, related substances, elemental impurities and microbiological testing. A documented SAMe disulfate-tosylate specification reports S,S-isomer ≥75.0%, SAMe ion 49.5–54.7%, p-toluenesulfonic acid 21.0–24.0%, water content ≤3.0%, sulphated ash ≤0.50% and total heavy metals ≤10 ppm. These parameters demonstrate the type of analytical controls that may be applied to commercial SAMe raw material.

MEDIOCON INC provides S-Adenosyl-L-Methionine for manufacturers and supplement companies requiring high-quality nutraceutical raw materials. Depending on the selected grade, customers can request the applicable Certificate of Analysis, specification sheet, technical data sheet and other available quality documentation. The exact salt form, assay basis, packaging, stability requirements and batch-specific analytical values should always be confirmed before commercial procurement.

The detailed limits above are based on a documented SAMe disulfate-tosylate commercial specification and COA.

Additional Quality Parameters

  • S,S-Isomer: NLT 75.0% by HPLC
  • SAMe Ion: 49.5–54.7% by HPLC
  • p-Toluenesulfonic Acid: 21.0–24.0%
  • Sulphate: 23.5–26.5%
  • Sulphated Ash: NMT 0.50%
  • Lead: NMT 3.0 ppm
  • Arsenic: NMT 2.0 ppm
  • Cadmium: NMT 1.0 ppm
  • Mercury: NMT 0.10 ppm
  • Total Aerobic Count: NMT 1000 cfu/g
  • Yeast & Mould: NMT 100 cfu/g
  • E. coli: Negative
  • Salmonella: Negative
  • Staphylococcus aureus: Negative

Product Specifications

Product NameS-Adenosyl-L-Methionine (SAMe) Manufacturer & Supplier in India | MEDIOCON INC
CAS Number485-80-3
CategoryNutraceutical
GradeNutraceutical
AppearanceWhite to off-white powder

Analytical Specifications

ParameterSpecification
AppearanceWhite to off-white powder

Sourcing, Regulatory & Export Information

Mediocon Inc is a GMP-certified API manufacturer and bulk pharmaceutical ingredient supplier based in Aurangabad, Maharashtra, India. We specialise in supplying S-Adenosyl-L-Methionine (SAMe) Manufacturer & Supplier in India | MEDIOCON INC (CAS 485-80-3) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our S-Adenosyl-L-Methionine (SAMe) Manufacturer & Supplier in India | MEDIOCON INC is manufactured under strict quality management protocols compliant with WHO-GMP, ISO 9001:2015, and major pharmacopoeial standards (IP, BP, USP, EP). Every batch undergoes full analytical testing before release with a Certificate of Analysis.

Export Markets

  • USA — FDA-registered facility; DMF support available for ANDA/NDA filings
  • Europe — EMA-compliant documentation; CEP/EDMF support on request
  • Africa & Middle East — WHO-GMP certified; competitive pricing for emerging markets
  • Southeast Asia — established logistics network; temperature-controlled shipments
  • India domestic — schedule H/X compliance; all state licensing documentation provided

Quality & Compliance

  • ISO 9001:2015 certified quality management system
  • GMP-certified manufacturing facility, Aurangabad, Maharashtra
  • Full batch traceability from raw material to finished API
  • Dedicated QA team for customer audits and regulatory queries

Frequently Asked Questions — S-Adenosyl-L-Methionine (SAMe) Manufacturer & Supplier in India | MEDIOCON INC

What is S-Adenosyl-L-Methionine?
S-Adenosyl-L-Methionine, commonly abbreviated as SAMe, is a naturally occurring sulfur-containing compound involved in biological methylation reactions. It is derived metabolically from L-methionine and ATP.
What is the CAS number of S-Adenosyl-L-Methionine?
The parent S-Adenosyl-L-Methionine is listed with CAS 485-80-3. Commercial SAMe is also commonly supplied as the disulfate tosylate salt, which has CAS 97540-22-2.
What is the molecular formula of S-Adenosyl-L-Methionine?
The parent S-Adenosyl-L-Methionine is listed as C15H23N6O5S⁺, with a molecular weight of 399.4 g/mol.
What is SAMe Disulfate Tosylate?
SAMe Disulfate Tosylate is a stabilized salt form of S-Adenosyl-L-Methionine used commercially as a raw material for nutraceutical and health-supplement products. USP lists the material under CAS 97540-22-2.
How is SAMe tested?
SAMe can be quantified using HPLC. Published analytical work has demonstrated reversed-phase HPLC methods for determining SAMe in dietary supplements and commercial health products.
Can MEDIOCON INC supply SAMe in bulk?
Yes. MEDIOCON INC can supply S-Adenosyl-L-Methionine/SAMe for commercial nutraceutical applications subject to the selected grade, formulation and applicable documentation.
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