N-Acetyl-L-Cysteine CAS 616-91-1 (Ac-Cys-OH; NAC) Assay 98.5~101.0% Factory High Quality

Short Description:

Chemical Name: N-Acetyl-L-Cysteine

Synonyms: Ac-Cys-OH; Acetylcysteine; NAC 

CAS: 616-91-1

Assay: 98.5~101.0% (on the Dried Basis) 

White Crystals or Crystalline Powder; Strongly Acid Taste

Amino Acids & Derivatives, High Quality 

Contact: Dr. Alvin Huang

Mobile/Wechat/WhatsApp: +86-15026746401

E-Mail: alvin@ruifuchem.com


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Description:

Shanghai Ruifu Chemical Co., Ltd. is the leading manufacturer and supplier of N-Acetyl-L-Cysteine (Ac-Cys-OH; NAC) (CAS: 616-91-1) with high quality. Ruifu Chemical supplys a series of amino acids and derivatives. Because of our excellent product quality, reasonable prices, we gained good reputation as well as trust from our at home and abroad customers. We can provide COA, worldwide delivery, small and bulk quantities available. If you are interested in N-Acetyl-L-Cysteine, Please contact: alvin@ruifuchem.com

Chemical Properties:

Chemical Name N-Acetyl-L-Cysteine 
Synonyms Ac-Cys-OH; Acetylcysteine; NAC; LNAC; N-Acetylcysteine; N-Acetyl-3-Mercaptoalanine; Acetyl-Laevo-Cysteine
Stock Status In Stock, Production Capacity 50 Tons per Month
CAS Number 616-91-1 
Molecular Formula C5H9NO3S
Molecular Weight 163.19  
Melting Point 106.0~108.0℃(lit.)
Sensitive Air Sensitive 
Water Solubility  Soluble in Water, Almost Transparency
Solubility  Soluble in Ethanol, Methanol, Alcohol. Practically Insoluble in Ether
Storage Temp.  Sealed in Dry, Store at Room Temperature
COA & MSDS Available
Classification Amino Acids & Derivatives 
Brand Ruifu Chemical

Safety Information:

Risk Statements 36/37/38 - Irritating to eyes, respiratory system and skin.
Safety Statements S22 - Do not breathe dust.  S24/25 - Avoid contact with skin and eyes.
WGK Germany 3
RTECS HA1660000
F 10-23
TSCA Yes
HS Code 2922491990

Specifications:

Items Inspection Standards Results
Appearance White Crystals or Crystalline Powder; Strongly Acid Taste Conforms          
Identification Infrared Absorption Spectrum Conforms
Specific Rotation [α]20/D +21.3° to +27.0° (C=5 in Phosphate Buffered Saline)
+23.5°
State of Solution (Transmittance) Clear and Colorless ≥98.0% 99.0%
Chloride (Cl) ≤0.040% <0.040%
Sulfate (SO4) ≤0.030% <0.030%
Ammonium (NH4) ≤0.020% <0.020%
Iron (Fe) ≤20ppm <20ppm
Heavy Metals (Pb) ≤10ppm <10ppm 
Zinc (Zn) ≤10ppm <10ppm 
Arsenic (As2O3) ≤1.0ppm <1.0ppm
Related Substances (HPLC Method)
L-Cystine ≤0.50%   Conforms
L-Cysteine ≤0.50%   Conforms
N,N'-Diacetyl-L-Cystine ≤0.50%   Conforms
N,S-Diacetyl-L-Cysteine ≤0.50%  Conforms
Each Other Impurity ≤0.50%  Conforms
Total Impurities ≤0.50%  Conforms
Loss on Drying ≤0.50% 0.20%
Residue on Ignition (Sulfated) ≤0.20% 0.05%
Assay 98.5 to 101.0% (on the Dried Basis)     99.90%
pH Value 2.0 to 2.8 (1.0g in 100ml of H2O) 2.5
Biochemical Toxicity Passes Passes
Volatile Organic Substances Pass  Pass 
Endonuclease Detection  ≤0.1 EU/g <0.1 EU/g  
Conclusion This Product by Inspection Accords with the Standard of AJI97
Main Uses Amino Acids; Food Additives; Pharmaceutical Intermediates

Process Flow Chart of N-Acetyl-L-Cysteine: 

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Package & Storage: 

Package: Fluorinated Bottle, Aluminium foil bag, 25kg/Cardboard Drum, or according to customer's requirement.

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Storage Condition: Store in sealed containers at cool, dry and ventilated warehouse away from incompatible substances. Protect from light and moisture.

AJI97 / USP35 Test Method:

N-Acetyl-L-Cysteine (Ac-Cys-OH; NAC) (CAS: 616-91-1) AJI97 Test Method
N-Acetyl-L-Cysteine, when dried, contains not less than 98.5 percent and not more than 101.0 percent of N-Acetyl-L-Cysteine (C5H9NO3S ).
Description: White crystals or crystalline powder, strongly acid taste.
Freely soluble in water, soluble in ethanol, practically insoluble in ether.
Solubility (H2O, g/100g): 17 (20℃), 80 (40℃), 260 (60℃)
Identification: Compare the infrared absorption spectrum of the sample with that of the standard by potassium bromide disc method.
Specific Rotation [α]20/D: Dried sample, C=8, phosphate buffer solution
State of Solution (Transmittance): 0.5g in 10ml of H2O, spectrophotometer, 430nm, 10mm cell thickness.
Heavy Metals (Pb): 2.0g, (1), ref: 2.0ml of Pb Std. (0.01mg/ml)
Zinc (Zn): Atomic absorption method
Related Substances: HPLC method
Loss on Drying: In vacuum, at 70℃ for 4 hours
Residue on Ignition (Sulfated): AJI Test 13
Assay: Dried sample, 200mg, 0.05mol/L I2 1ml=16.320mg C5H9NO3S
pH: 1.0g in 100ml of H2O
Recommended storage limit and condition: Preseved tight containers at controlled room temperature (1 years).

N-Acetyl-L-Cysteine (Ac-Cys-OH; NAC) (CAS: 616-91-1) USP35 Test Method
DEFINITION
Acetylcysteine contains NLT 98.0% and NMT 102.0% of L-threonine (C5H9NO3S), calculated on the dried basis.
IDENTIFICATION
A. INFRARED ABSORPTION <197K>
ASSAY
PROCEDURE
Mobile phase: 6.8 g/L of monobasic potassium phosphate. Adjust with phosphoric acid to a pH of 3.0.
Sodium metabisulfite solution: 0.5 mg/mL of sodium metabisulfite in water, freshly prepared
Internal standard solution: 5 mg/mL of USP L-Phenylalanine RS in Sodium metabisulfite solution
Standard stock solution: 10 mg/mL of USP Acetylcysteine RS in Sodium metabisulfite solution
Standard solution: 0.5 mg/mL of USP Acetylcysteine RS and 0.25 mg/mL of USP L-Phenylalanine RS in Sodium metabisulfite solution from Standard stock solution and Internal standard solution
Sample stock solution: 10 mg/mL of Acetylcysteine in Sodium metabisulfite solution
Sample solution: 0.5 mg/mL of Acetylcysteine and 0.25mg/mL of USP L-Phenylalanine RS in Sodium metabisulfite solution from Sample stock solution and Internal standard solution
Chromatographic system
(See Chromatography <621>, System Suitability.)
Mode: LC
Detector: UV 214 nm
Column: 3.9-mm × 30-cm; packing L1
Flow rate: 1.5 mL/min
Injection size: 5 µL
System suitability
[NOTE-The relative retention times for acetylcysteine and L-phenylalanine are about 0.5 and 1.0, respectively.]
Suitability requirements
Resolution: NLT 6 between acetylcysteine and L-phenylalanine
Relative standard deviation: NMT 2.0%
Analysis
Samples: Standard solution and Sample solution
Calculate the percentage of acetylcysteine (C5H9NO3S) in the portion of Acetylcysteine taken:
Result = (RU/RS) × (CS/CU) × 100
RU = peak response ratio of acetylcysteine to L-phenylalanine from the Sample solution
RS = peak response ratio of acetylcysteine to L-phenylalanine from the Standard solution
CS = concentration of USP Acetylcysteine RS in the Standard solution (mg/mL)
CU = concentration of acetylcysteine in the Sample solution (mg/mL)
Acceptance criteria: 98.0%-102.0% on the dried basis
IMPURITIES
RESIDUE ON IGNITION <281>: NMT 0.5%
HEAVY METALS, Method II <231>
[CAUTION-Exercise care because explosion may occur.]
Analysis: In a dropwise manner, wet the sample with 2 mL of nitric acid, and proceed as directed for the Test preparation.
Acceptance criteria: NMT 10 ppm
SPECIFIC TESTS
OPTICAL ROTATION, Specific Rotation <781S>
Buffer: Mix 29.5 mL of 1 N sodium hydroxide, 50 mL of 1 M monobasic potassium phosphate, and sufficient water to make 100 mL. Adjust to a pH of 7.0 ± 0.1 by adding more of either solution, as necessary.
Sample solution: In a 25-mL volumetric flask, mix 1.25 g with 1 mL of edetate disodium solution (1 in 100), add 7.5mL of sodium hydroxide solution (1 in 25), and mix to dissolve. Dilute with Buffer to volume.
Acceptance criteria: +21° to +27°
pH <791>: 2.0-2.8 in a solution (1 in 100)
LOSS ON DRYING <731>: Dry a sample at a pressure of about 50 mm of mer cury at 70° for 4 h: it loses NMT 1.0% of its weight.
ADDITIONAL REQUIREMENTS
PACKAGING AND STORAGE: Preserve in tight containers, and store at controlled room temperature.
USP REFERENCE STANDARDS <11>
USP Acetylcysteine RS
USP L-Phenylalanine RS

Advantages:

Sufficient Capacity: Sufficient facilities and technicians

Professional Service: One stop purchasing service

OEM Package: Custom package and label available

Fast Delivery: If within stock, three days delivery guaranteed

Stable Supply: Maintain reasonable stock    

Technical Support: Technology solution available

Custom Synthesis Service: Ranged from grams to kilos

High Quality: Established a complete quality assurance system

FAQ:

How to Purchase? Please contact Dr. Alvin Huang: sales@ruifuchem.com or alvin@ruifuchem.com 

15 Years Experience? We have more than 15 years of experience in the manufacture and export of a wide range of high quality pharmaceutical intermediates or fine chemicals.

Main Markets? Sell to domestic market, North America, Europe, India, Korea, Japanese, Australia, etc.

Advantages? Superior quality, affordable price, professional services and technical support, fast delivery.

Quality AssuranceStrict quality control system. Professional equipment for analysis include NMR, LC-MS, GC, HPLC, ICP-MS, UV, IR, OR, K.F, ROI, LOD, MP, Clarity, Solubility, Microbial limit test, etc.

SamplesMost products provide free samples for quality evaluation, shipping cost should be paid by customers.

Factory AuditFactory audit welcome. Please make an appointment in advance.

MOQ? No MOQ. Small order is acceptable.

Delivery Time? If within stock, three days delivery guaranteed.

TransportationBy Express (FedEx, DHL), by Air, by Sea.

Documents? After sales service: COA, MOA, ROS, MSDS, etc. can be provided.

Custom SynthesisCan provide custom synthesis services to best fit your research needs.

Payment TermsProforma invoice will be sent first after confirmation of order, enclosed our bank information. Payment by T/T (Telex Transfer), PayPal, Western Union, etc. 

Application:

Function & Application of N-Acetyl-L-Cysteine (Ac-Cys-OH; NAC) (CAS: 616-91-1) powder
1. N-Acetyl-L-Cysteine, also known as N-Acetylcysteine or Acetylcysteine (NAC), is a pharmaceutical drug and nutritional supplement used primarily as a mucolytic agent and in the management of paracetamol (acetaminophen) overdose. Other uses include sulfate repletion in conditions, such as autism, where cysteine and related sulfur amino acids may be depleted.
2. N-Acetyl-L-Cysteine is a derivative of cysteine where an acetyl group is attached to the nitrogen atom. This compound is sold as a dietary supplement commonly claiming antioxidant and liver protecting effects. It is used as a cough medicine because it breaks disulfide bonds in mucus and liquefies it, making it easier to cough up. It is also this action of breaking disulfide bonds that makes it useful in thinning the abnormally thick mucus in cystic and pulmonary fibrosis patients.
3. Acetylcysteine is a mucolytic agent with strong mucolytic effect. The sulfhydryl group contained in the molecule can break the disulfide bond in the glycoprotein polypeptide chain in the sputum, thereby reducing the viscosity of the sputum, and making the sputum liquid and easy to cough up. This product can also break DNA fibers in purulent sputum, so it can not only dissolve white sticky sputum, but also purulent sputum. For patients whose general expectorants are ineffective, this product can still be effective.
4. It is used as a medicine to dissolve phlegm. It is used in biochemical research and medicine as an antidote for phlegm and acetaminophen poisoning. Biochemical reagent, medicine, this product is used as expectorant, said that phlegm is easy to clean.
5. Common side effects include nausea and vomiting when taken by mouth.The skin may occasionally become red and itchy with either form. A non-immune type of anaphylaxis may also occur. It appears to be safe in pregnancy. For paracetamol overdose, it works by increasing the level of glutathione, an antioxidant that can neutralise the toxic breakdown products of paracetamol. When inhaled, it acts as a mucolytic by decreasing the thickness of mucus.
6. Acetylcysteine was initially patented in 1960 and came into medical use in 1968. It is on the World Health Organization's List of Essential Medicines, which lists the safest and most effective medicines needed in a health system. It is available as a generic medication and is inexpensive.
7. N-Acetyl-L-Cysteine is the acetylated form of L-cysteine which is more efficiently absorbed and used. It is also an antioxidant that is helpful against viruses. N-Acetyl-l-Cysteine has been used as a liver protectant and to break up pulmonary and bronchial mucus.
8. N-Acetyl-L-Cysteine can boost glutathione levels in cells.
9. N-Acetyl-L-Cysteine is a conditionally essential amino acid, one of only three sulfur-containing amino acids, the others being taurine (which can be produced from L-cysteine) and L-methionine from which L-cysteine can be produced in the body by a multi-step process.
10. N-Acetyl-L-Cysteine can act as an antioxidant, may prevent liver diseases, and can help to thicken the individual diameters of existing hair if taken regularly.
11. Application in medical fields As Respiratory system agent, it can be used as medicine for dissolving phlegm drums. it can cure bronchitis. moreover, N-Acetyl-L-Cysteine can used as antidote when acetaminophen poisoning.
12. Application in cosmetic fields N-Acetyl-L-Cysteine have a great effect in clearing oxygen free radicals and other oxides and slowing the aging process, it also can disturb the melanin production, and is helpful to eliminate the freckle on the skin
13. Application in animal feed N-Acetyl-L-Cysteine can be used as feed additive.
14. Cosmetics mainly used for beauty water, perm fluid, sun-proof skin care cream. Has a function to prevent biological aging. N-Acetyl-l-Cysteine can effectively prevent and treat radiation injury. N-acetyl Cysteine can remove the skin melanin itself, change the nature of the skin itself, the skin becomes natural whitening.It is a kind of ideal natural whitening cosmetics.
15. Food additive. Used in bread, to promote the formation of gluten and promote fermentation, mold, prevent aging. Used in natural juices to prevent vitamin C from oxidizing and to prevent the juices from turning brown. 

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