CERTIFICATE OF ANALYSIS
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Product: N-Acetyl-L-Cysteine CAS No: (616-91-1) Quantity: 1000kg Lot No: Date: OCT 25, 2024 |
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Item |
Specification |
Result |
|
Appearance |
White crystals or crystalline powder |
Conforms |
|
Identification |
Infrared Absorption |
Conforms |
|
Specific rotation [ α]D20 |
+21.3 °to +27.0 ° |
+23.0 ° |
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State of solution (Transmittance) |
Clear and colorless Not less than 98.0% |
99.7% |
|
Chloride(Cl) |
Not more than 0.04% |
<0.04% |
|
Ammonium(NH4) |
Not more than 0.02% |
<0.02% |
|
Sulfate(SO4) |
Not more than 0.03% |
<0.03% |
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Iron (Fe) |
Not more than 20ppm |
<20ppm |
|
Heavy metals (Pb) |
Not more than 10ppm |
<10ppm |
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Arsenic (As2O3) |
Not more than 1ppm |
<1ppm |
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Other amino acids |
Chromatographically not detectable |
Conforms |
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Loss on Drying |
Not more than 0.5% |
0.08% |
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Residue on ignition (sulfated) |
Not more than 0.20% |
0.1% |
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Assay |
98.5 to 101.0% (Calculated on the dried basis) |
99.8% |
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pH |
2.0 to 2.8 |
2.2 |
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Melting point |
106 to 110℃ |
Conforms |
Conclusion: Agree with the specification of AJI92.
| Product Name: | N-Acetyl-L-cysteine | Other Name: | L-Cysteine,N-acetyl-;Cysteine,N-acetyl-,L-;N-Acetyl-L-cysteine;N-Acetylcysteine;Acetylcysteine;Mercapturic acid;Mucomyst;Mercapturic acid,(R)-;Airbron;Fluimucil;Fluimucetin;Respaire;Mucolyticum-Lappe;L-Acetylcysteine;Parvolex;Mucolytikum Lappe;Broncholysin;NSC 111180;Broncholysin (mucolytic);Mucosolvin;N-Acetyl-(R)-cysteine;Mucofilin;L-N-Acetylcysteine;Fluimicil;Fluimicil Infantil;Fluibiotic;Nα-Acetylcysteine;Exomuc;(R)-N-Acetylcysteine;Tixair;Muco Sanigen;Brunac;Fluatox;Mucocedyl;Mucolator;Neo-Fluimucil;Fabrol;Mucolyticum;Mucret;Fluprowit;Acetilcysteina;ACC;Flumil;Syntemucol;Hypotears;Lysomucil;Fluimucil Antidot;Acetadote;Mucosten;Asist;Trom;Mentopin;Mucomelt;Mucinac;(2R)-2Acetamido-3-sulfanylpropanoic acid;Cysteplus;Ac-Cys-OH;(2R)-2-Acetamido-3-sulfanylpropanoic acid;7696-05-1;1261105-20-7 |
| CAS No.: | 616-91-1 | Molecular Formula: | C5H9NO3S |
| InChIKeys: | InChIKey=PWKSKIMOESPYIA-BYPYZUCNSA-N | Molecular Weight: | 163.19 |
| Exact Mass: | 163.19 | BRN: | 1724426 |
| EC Number: | 210-498-3 | UNII: | WYQ7N0BPYC |
| DSSTox ID: | DTXSID5020021 | NCI Thesaurus Code: | C200 |
| Color/Form: | Crystals from water|WHITE, CRYSTALLINE POWDER | ATC Code: | R05CB01|R – Respiratory system|S – Sensory organs|V – Various |
| HScode: | 29309016 | Categories: | Amino Acids and Derivatives |
| PSA: | 67.4 | XLogP3: | 0.4 |
| Appearance: | White Solid | Density: | 1.3±0.1 g/cm3 |
| Melting Point: | 109.5 °C | Boiling Point: | 407.7°C at 760 mmHg |
| Flash Point: | 200.4±27.3 °C | Refractive Index: | 1.519 |
| Water Solubility: | soluble in water, ethanol, methanol, dimethyl sulfoxide, hot isopropyl alcohol, methyl acetate and ethyl acetate. Insoluble in chloroform and ether.H2O: 100 mg/mL with heating | Storage Conditions: | 2-8°C |
| Vapor Pressure: | 1.1X10-5 mm Hg at 25 deg C /Estimated/ | Toxicity: | Oral-rat LD50:5050 mg/kg; Oral-Mouse LD50:7888 mg/kg |
| Flammability characteristics: | Decomposes smoke in humid air; burning releases toxic nitrogen oxide and sulfur oxide smoke | Specific rotation: | -35.1 ºC (c=2,H2O) |
| Odor: | SLIGHT ACETIC ODOR | Taste: | CHARACTERISTIC SOUR TASTE |
| PH: | 2 TO 2.75 (1 IN 100 ML) | PKA: | 9.52(at 25 °C) |
| Henrys Law Constant: | Henry’s Law constant = 1.7X10-13 atm-cu m/mole at 25 °C /Estimated/ | Dissociation Constants: | 9.52 (at 25 °C)|pKa= 3.24 (carboxylic acid moiety)|pKa = 9.52 (SH group) |
| Collision Cross Section: | 140.9 Ų [M+Na]+ [CCS Type: DT, Method: single field calibrated with ESI Low Concentration Tuning Mix (Agilent)]|140.9 Ų [M+Na]+ | Experimental Properties: | It is stable in ordinary light, nonhygroscopic (oxidizes in moist air), and stable at temperatures up to 120 °C|Hydroxyl radical reaction rate constant = 5.5X10-11 cu cm/molec-sec at 25 °C /Estimated/ |
Classification of the substance or mixture
Not classified.
GHS label elements, including precautionary statements
| Pictogram(s) | No symbol. |
|---|---|
| Signal word |
No signal word |
| Hazard statement(s) |
none |
| Precautionary statement(s) | |
| Prevention |
none |
| Response |
none |
| Storage |
none |
| Disposal |
none |
Other hazards which do not result in classification
no data available
Precautions for safe handling
Handling in a well ventilated place. Wear suitable protective clothing. Avoid contact with skin and eyes. Avoid formation of dust and aerosols. Use non-sparking tools. Prevent fire caused by electrostatic discharge steam.
Conditions for safe storage, including any incompatibilities
Unopened vials of acetylcysteine sodium solution should be stored at 15-30 deg C. Following exposure to air, solutions should be stored at 2-8 deg C to retard oxidation and should be used within 96 hr.