Nutraceutical

S-Adenosyl-L-Methionine Disulfate Tosylate Manufacturer & Supplier in India | MEDIOCON INC

CAS: 97540-22-2 Nutraceutical Nutraceutical GMP Certified Aurangabad, Maharashtra, India
S-Adenosyl-L-Methionine Disulfate Tosylate Manufacturer & Supplier in India | MEDIOCON INC — Mediocon Inc
S-Adenosyl-L-Methionine Disulfate Tosylate Manufacturer & Supplier in India | MEDIOCON INC

Product Overview

CAS No: 97540-22-2 | Grade: Nutraceutical | Category: Nutraceutical

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

S-Adenosyl-L-Methionine Disulfate Tosylate (SAMe) is a stabilized salt form of S-adenosyl-L-methionine, a naturally occurring sulfur-containing compound involved in biological methylation reactions. S-adenosyl-L-methionine acts as a methyl-group donor in numerous biochemical reactions and is commercially used as an ingredient for health supplements and nutraceutical formulations. The disulfate-tosylate form combines the S-adenosyl-L-methionine ion with sulfate and p-toluenesulfonate components in a defined salt system. USP recognizes S-Adenosyl-L-Methionine Disulfate Tosylate as a dietary-supplement ingredient with a defined composition and quality requirements.

MEDIOCON INC supplies S-Adenosyl-L-Methionine Disulfate Tosylate as a premium raw material for health-supplement and nutraceutical applications. Commercial specifications describe the material as a white to off-white powder, with quality parameters including identification by infrared/HPLC, assay of approximately 95.0–103.0% or 95.0–105.0% depending on the applicable specification, S,S-isomer content of at least 75.0%, and SAM-e ion content of 49.5–54.7%. The precise release specification should always be determined by the applicable product standard and batch COA.

The chemical identity of the disulfate-tosylate salt is distinct from the parent S-adenosyl-L-methionine molecule. The complete salt has CAS No. 97540-22-2, molecular formula C₂₂H₃₄N₆O₁₆S₄, and molecular weight approximately 766.8 g/mol. The parent SAMe ion has a different molecular composition and molecular weight, so the parent-compound values should not be entered into the CMS fields for the disulfate-tosylate product. PubChem and FDA substance records both identify the disulfate-tosylate salt as a defined chemical substance.

For nutraceutical formulation, quality control of SAMe Disulfate Tosylate commonly includes assay, S,S-isomer ratio, SAM-e ion, p-toluenesulfonic acid, sulfate content, moisture, sulphated ash, related substances, heavy metals and microbiological parameters. A documented commercial specification reports S,S-isomer NLT 75.0%, SAM-e ion 49.5–54.7%, p-toluenesulfonic acid 21.0–24.0%, sulfate 23.5–26.5%, and total impurities NMT 3.5%.

MEDIOCON INC can supply S-Adenosyl-L-Methionine Disulfate Tosylate for manufacturers and supplement companies requiring a defined SAMe raw material. Customers can request the applicable Certificate of Analysis (COA), specification sheet, Technical Data Sheet (TDS), Safety Data Sheet (SDS) and other available quality documents. The final commercial specification, storage requirements, packaging and intended use should be confirmed against the actual batch and destination-market requirements.

Additional Quality Parameters

  • S,S-Isomer: NLT 75.0% by HPLC
  • SAM-e Ion: 49.5–54.7%
  • p-Toluenesulfonic Acid: 21.0–24.0%
  • Sulfate (SO₄): 23.5–26.5%
  • Sulphated Ash: NMT 0.50%
  • Lead: NMT 3 ppm
  • Arsenic: NMT 2 ppm
  • Cadmium: NMT 1 ppm
  • Mercury: NMT 0.1 ppm
  • Total Aerobic Count: NMT 1000 cfu/g
  • Yeast & Mould: NMT 100 cfu/g
  • E. coli: Absent/Negative
  • Salmonella: Negative
  • Staphylococcus aureus: Negative

These are reference specifications from documented commercial SAMe Disulfate Tosylate materials and should not be presented as MEDIOCON batch results unless supported by MEDIOCON's own COA.

Product Specifications

Product NameS-Adenosyl-L-Methionine Disulfate Tosylate Manufacturer & Supplier in India | MEDIOCON INC
CAS Number97540-22-2
CategoryNutraceutical
GradeNutraceutical
AppearanceWhite to off-white powder

Analytical Specifications

ParameterSpecification
AppearanceWhite to off-white powder
IdentificationMolecular Formula
Assay (HPLC)C₂₂H₃₄N₆O₁₆S₄
Loss on DryingMolecular Weight
Residue on Ignition766.8 g/mol
Heavy MetalsAssay
pH (1% Solution)95.0–103.0%
Individual ImpurityS,S-Isomer
Total ImpuritiesNLT 75.0% by HPLC
Water ContentSAM-e Ion
Specific Rotation49.5–54.7% by HPLC
Melting PointMelting Point
Solubility>122°C with decomposition reported for the material

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 Disulfate Tosylate Manufacturer & Supplier in India | MEDIOCON INC (CAS 97540-22-2) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our S-Adenosyl-L-Methionine Disulfate Tosylate 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 Disulfate Tosylate Manufacturer & Supplier in India | MEDIOCON INC

What is S-Adenosyl-L-Methionine Disulfate Tosylate?
S-Adenosyl-L-Methionine Disulfate Tosylate is a defined salt form of S-adenosyl-L-methionine consisting of the SAMe ion together with sulfate and p-toluenesulfonate components. USP recognizes it as a dietary-supplement ingredient.
What is the CAS number of SAMe Disulfate Tosylate?
The primary CAS number is 97540-22-2. PubChem and FDA substance records identify this CAS for S-Adenosyl-L-Methionine Disulfate Tosylate.
What is the molecular formula?
The molecular formula is C₂₂H₃₄N₆O₁₆S₄.
What is the molecular weight?
The molecular weight is approximately 766.8 g/mol.
What is the appearance of SAMe Disulfate Tosylate?
Commercial specifications describe it as a white to off-white powder.
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