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Paracetamol
Paracetamol
CAS No.:103-90-2
Molecular Formula:C8H9NO2
Molecular Weight:151.16
PRODUCT NAME:Paracetamol

Paracetamol, also known as acetaminophen or APAP, is a medicine used to treat pain and fever. It is typically used for mild to moderate pain relief. Evidence for its use to relieve fever in children is mixed. It is often sold in combination with other medications, such as in many cold medications. In combination with opioid pain medication, paracetamol is also used for severe pain such as cancer pain and pain after surgery. It is typically used either by mouth or rectally but is also available intravenously. Effects last between two and four hours. Paracetamol is generally safe at recommended doses. Serious skin rashes may rarely occur, and too high a dose can result in liver failure. It appears to be safe during pregnancy and when breastfeeding. In those with liver disease, it may still be used, but in lower doses. Paracetamol is classified as a mild analgesic. It does not have significant anti-inflammatory activity and how it works is not entirely clear. Paracetamol was discovered in 1877. It is the most commonly used medication for pain and fever in both the United States and Europe. It is on the World Health Organization's List of Essential Medicines, the most effective and safe medicines needed in a health system. Paracetamol is available as a generic medication with trade names including Tylenol and Panadol among others. The wholesale price in the developing world is less than 0.01 USD per dose. In the United States it costs about 0.04 USD per dose.

  1. Paracetamol is used for reducing fever in people of all ages.
  2. Paracetamol is used for the relief of mild to moderate pain. The use of the intravenous form for pain of sudden onset in people in the emergency department is supported by limited evidence.
  3. Based on a systematic review, paracetamol is recommended by the American College of Physicians and the American Pain Society as a first-line treatment for low back pain. In contrast, other systematic reviews have concluded that evidence for its efficacy is lacking.
  4. Paracetamol combined with NSAIDs may be more effective for treating postoperative pain than either paracetamol alone or NSAIDs alone.

 Paracetamol is particularly useful when NSAIDs are contraindicated due to hypersensitivity or history of gastrointestinal ulceration or bleeding. It can also be used in combination with NSAIDs when these are ineffective in controlling dental pain alone.

Product name

Acetaminophen (Paracetamol)

Batch NO

202210048A

Packing

25kg/bag

Quantity

5675kg

MFG, Date

2022.10.09

EXP. Date

2026.10.08

Analysis Date

2022.10.13

Check NO.

221013-02

Standard

EP9.0/BP2018

Tests

Specification

Results

 

Characters

Appearance

A white or almost white, crystalline powder

Conforms

Solubility

Sparingly soluble in water, freely soluble in alcohol, very slightly soluble in methylene chloride

Conforms

 

Identification

Mp

168℃~172℃

170.0-170.5℃

IR

Consistent with the spectrum of paracetamol CRS

Conforms

Loss on drying

≤0.5%

0.06%

Sulphated ash

≤0.1%

0.04%

 

 

 

Related

substances

Impurity J

(4-Chloroacetanilide)≤10 ppm

Below LOD

Impurity K

(4-Aminophenol)≤50ppm

Below LOD

Impurity F

(4-nitrophenol)≤0.05%

Below LOD

Any      other impurity

≤0.05%

<0.05%

Total of other impurities

≤0.1%

<0.1%

Assay

99.0%-101.0%

99.5%

Conclusion: It complies with the requirements of EP9.0/BP2018

 

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