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Sinoway Industrial Co. Ltd
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Product name
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Ademetionine 1,4-butanedisulfonate / SAM / SAMe
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CAS No.
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101020-79-5
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Molecular Formula
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C23H41N6O17S5-
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Molecular Weight
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833.91
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Quality Standard
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99% up by HPLC
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Appearance
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White powder
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COA of Ademetionine 1,4-butanedisulfonate
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ITEMS
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STANDARDS
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RESULTS
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Appearance
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A white or almost white powder
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White powder
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Solubility
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Freely soluble in water, practically insoluble in ethanol and in acetone.
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Conforms
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Identification
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1. The gas it produced can make wet potassium iodate test pater show blue.
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Conforms
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2. UV: it has absorption maximum at the 258nm
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3. HPLC: the retention time of the principal peak in the chromatogram obtained with test solution is in accordance with that of the reference.
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pH
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2.1~2.5
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2.4
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Clarity and color of solution
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Color: ≤Y3# or YG3#
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Conforms
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A solution should be clear.
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Isomers
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(S,S-Isomer) ≥70%
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74.00%
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Related substances
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Adenine≤0.4%
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0.05%
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S-Adenosyl-L-Homocysteine≤0.4%
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0.09%
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Methylthioadenosine≤2.0%
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0.43%
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Decarboxylation adenosine methionine≤1.2%
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1.00%
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The other unknown impurities≤1.0%
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0.05%
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Total of impurities≤4.0%
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1.80%
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Water
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≤6.0%
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2.40%
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Residual solvents
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Ethyl acetate≤5000ppm
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Conforms
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Microbial limit tests
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Bacteria≤1000cfu/g
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Conforms
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Bacterial endotoxins
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≤0.438 EU/mg
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Conforms
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Content (dried basis)
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Butanedisuphonic acid: 46.0~51.0%
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47.20%
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Adenosine methionine: 48.0~53.0%
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52.20%
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Total≥96.0%
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99.40%
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Conclusion
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Conforms to enterprise standard
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Function of Ademetionine 1,4-butanedisulfonate
Ademetionine 1,4-butanedisulfonate (SAM / SAMe) is a physiologically active molecule commonly found in human tissues and body fluids. It acts as a methyl donor (transmethylation) and a precursor of physiological sulfhydryl compounds (such as cysteine, taurine, glutathione, coenzyme A, etc.) (transsulfation) , participates important functions of biochemical reaction in the body.
The multiple mechanisms of adenosylmethionine are mainly reflected in the following aspects:
1. Transmethylation: Improve liver cell membrane fluidity, enhance Na+-K+-ATPase activity, promote bile secretion and operation, and participate in neurotransmitter synthesis, which can improve patient mood.
2. Transsulfide group: generate endogenous antidote, such as cysteine, glutathione, taurine, etc., play detoxification and antioxidant effects, and reduce liver cell damage.
3. Transformation of propylamino group: Synthesize biological polyamines, participate in metabolism in the body, regulate the regeneration and proliferation of liver cells, and accelerate the repair of liver function.
Indication of Ademetionine 1,4-butanedisulfonate:
Suitable for intrahepatic cholestasis before and after cirrhosis.
Suitable for intrahepatic cholestasis during pregnancy. |
Send Inquiry
|
|
Sinoway Industrial Co. Ltd
|
|
Product name
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Ademetionine 1, 4-butanedisulfonate;
|
|
CAS No.
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101020-79-5
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Molecular Formula
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2(C15H23N6O5S).2(C4H10O6S2).C4H8O6S2
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Molecular Weight
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1451.63
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Quality Standard
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Ademetionine: 50.0 - 54.0% by HPLC;
1,4-butanedisulfonate: 46.0%–49.0% by HPLC
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Appearance
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White to off-white Powder
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Test Items
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Specifications
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Results
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|
Appearance
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White to off-white Powder
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White crystalline powder
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HPLC
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The retention time of the major peak corresponds to the reference sample.
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Complied
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|
Specific Rotation
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+28° ～ +34°
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+30°
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Water
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3.0% MAX
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2.2%
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PH (0.4% AQUEOUS SOLUTION)
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1.8 -2.5
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2.2
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Residue on ignition
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≤ 0.5%
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0.3%
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Heavy Metals
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Not more than 10 ppm
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Complied
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Content of Ademetionine(HPLC)
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50.0 - 54.0%
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50.1%
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Content of 1,4-butanedisulfonate
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46.0%–49.0%
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48.6%
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S,S-isomer
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≥ 60%
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77.5%
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Related substances(HPLC):
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|
|
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- ADENINE
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0.5% MAX.
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0.1%
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- S-ADENOSYL-L-HOMOCYSTEINE
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0.5% MAX.
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0.05%
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- METHYLTHIOADENOSINE
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0.5% MAX.
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0.2%
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OTHER INDIVIDUAL IMPURITY
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0.1% MAX.
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0.09%
|
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- TOTAL OTHER IMPURITIES
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1.0% MAX.
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0.4%
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- TOTAL IMPURITIES
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2.5% MAX.
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0.8%
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ASSAY
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≥ 97.0%
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98.7%
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Bacterual endtoxin :
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≤ 0.25EU/mg
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Complied
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Microbiology :
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|
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Total Aerobic Count
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≤ 200cfu/g
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Complied
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Total Combined Yeasts
and Molds Count
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≤ 100cfu/g
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Complied
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E. coli
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Absent/10g
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Complied
|
|
Conclusion
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Complies with Enterprise standard
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Functions of Ademetionine 1,4-Butanedisulfonate
Ademetionine 1,4-butanedisulfonate (SAMe-1,4-BDS) is a stable salt form of S-adenosylmethionine (SAMe), a naturally occurring compound in the human body. Its primary functions include:
1. Liver Health:Promotes hepatocyte regeneration and detoxification. Used to treat liver disorders (e.g., cirrhosis, hepatitis, cholestasis) by enhancing glutathione synthesis and reducing oxidative stress.
2. Neurological and Psychiatric Applications: Modulates neurotransmitter synthesis (e.g., serotonin, dopamine), supporting the treatment of depression, anxiety, and cognitive disorders.
3. Joint Health: Stimulates proteoglycan synthesis in cartilage, aiding in osteoarthritis management.
4. Enhanced Stability: The 1,4-butanedisulfonate salt improves SAMe’s stability and bioavailability, ensuring longer shelf life and better therapeutic efficacy compared to free SAMe.
China holds significant competitive advantages in producing SAMe-1,4-butanedisulfonate:
1. Scalable Production: Large-scale fermentation and chemical synthesis facilities support high-volume output to meet global demand.
2. Advanced Technology: Adoption of cutting-edge biotechnological processes (e.g., microbial fermentation, enzymatic conversion) ensures high-purity SAMe synthesis.
3. Supply Chain Integration: Well-established raw material networks (e.g., methionine, ATP precursors) reduce lead times and production costs.
Customization Capabilities: Flexibility to produce tailored formulations (e.g., injectables, oral tablets) for diverse clinical needs.
|
Send Inquiry
|
|
Sinoway Industrial Co. Ltd
|
|
Product name
|
Ademetionine 1, 4-butanedisulfonate;
|
|
CAS No.
|
101020-79-5
|
|
Molecular Formula
|
2(C15H23N6O5S).2(C4H10O6S2).C4H8O6S2
|
|
Molecular Weight
|
1451.63
|
|
Quality Standard
|
Ademetionine: 50.0 - 54.0% by HPLC;
1,4-butanedisulfonate: 46.0%–49.0% by HPLC
|
|
Appearance
|
White to off-white Powder
|
|
Test Items
|
Specifications
|
Results
|
|
Appearance
|
White to off-white Powder
|
White crystalline powder
|
|
HPLC
|
The retention time of the major peak corresponds to the reference sample.
|
Complied
|
|
Specific Rotation
|
+28° ～ +34°
|
+30°
|
|
Water
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3.0% MAX
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2.2%
|
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PH (0.4% AQUEOUS SOLUTION)
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1.8 -2.5
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2.2
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Residue on ignition
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≤ 0.5%
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0.3%
|
|
Heavy Metals
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Not more than 10 ppm
|
Complied
|
|
Content of Ademetionine(HPLC)
|
50.0 - 54.0%
|
50.1%
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Content of 1,4-butanedisulfonate
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46.0%–49.0%
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48.6%
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|
S,S-isomer
|
≥ 60%
|
77.5%
|
|
Related substances(HPLC):
|
|
|
|
- ADENINE
|
0.5% MAX.
|
0.1%
|
|
- S-ADENOSYL-L-HOMOCYSTEINE
|
0.5% MAX.
|
0.05%
|
|
- METHYLTHIOADENOSINE
|
0.5% MAX.
|
0.2%
|
|
OTHER INDIVIDUAL IMPURITY
|
0.1% MAX.
|
0.09%
|
|
- TOTAL OTHER IMPURITIES
|
1.0% MAX.
|
0.4%
|
|
- TOTAL IMPURITIES
|
2.5% MAX.
|
0.8%
|
|
ASSAY
|
≥ 97.0%
|
98.7%
|
|
Bacterual endtoxin :
|
≤ 0.25EU/mg
|
Complied
|
|
Microbiology :
|
|
|
|
Total Aerobic Count
|
≤ 200cfu/g
|
Complied
|
|
Total Combined Yeasts
and Molds Count
|
≤ 100cfu/g
|
Complied
|
|
E. coli
|
Absent/10g
|
Complied
|
|
Conclusion
|
Complies with Enterprise standard
|
Functions of Ademetionine 1,4-Butanedisulfonate
Ademetionine 1,4-butanedisulfonate (SAMe-1,4-BDS) is a stable salt form of S-adenosylmethionine (SAMe), a naturally occurring compound in the human body. Its primary functions include:
1. Liver Health:Promotes hepatocyte regeneration and detoxification. Used to treat liver disorders (e.g., cirrhosis, hepatitis, cholestasis) by enhancing glutathione synthesis and reducing oxidative stress.
2. Neurological and Psychiatric Applications: Modulates neurotransmitter synthesis (e.g., serotonin, dopamine), supporting the treatment of depression, anxiety, and cognitive disorders.
3. Joint Health: Stimulates proteoglycan synthesis in cartilage, aiding in osteoarthritis management.
4. Enhanced Stability: The 1,4-butanedisulfonate salt improves SAMe’s stability and bioavailability, ensuring longer shelf life and better therapeutic efficacy compared to free SAMe.
China holds significant competitive advantages in producing SAMe-1,4-butanedisulfonate:
1. Scalable Production: Large-scale fermentation and chemical synthesis facilities support high-volume output to meet global demand.
2. Advanced Technology: Adoption of cutting-edge biotechnological processes (e.g., microbial fermentation, enzymatic conversion) ensures high-purity SAMe synthesis.
3. Supply Chain Integration: Well-established raw material networks (e.g., methionine, ATP precursors) reduce lead times and production costs.
Customization Capabilities: Flexibility to produce tailored formulations (e.g., injectables, oral tablets) for diverse clinical needs.
|
Send Inquiry
|
Pharma Sources Insight January 2025
