Tag Archives: API

India restricts exports of 26 APIs and preparations

  1. 限制出口的清单(见附件),以及英文新闻链接
    https://www.abc.net.au/news/2020-03-05/fear-of-medicine-shortage-spreads-as-india-limits-exports/12026762

    • The Indian Government said there were enough stocks to manufacture formulations for up to three months
    • The export restriction list includes several antibiotics, the hormone progesterone and vitamin B12
    • It is unclear how the restriction would impact the availability of these medicines in countries that import from India 
  2. 限制出口的原因:受疫情影响,需要优先供应印度国内 Reasons for export restrictions: Affected by the corona-virus, Priority is given to protecting the domestic market

  3. 对中国及其他国家的影响 Impact on China and other countries & areas

    • 据外媒报道,部分关键原料药已经上涨10% – 50% According to foreign media reports, some key APIs have risen by 10%-50%
    • 全球需求急剧增长,中国企业产能还没有完全恢复,中国的原料药及中间体涨价已成定局 Global demand has increased sharply, however Manufacture industry in China has not yet fully recovered, under such, Prices of APIs & intermediates in China will be keep rising.
    • 对于中国的制剂厂来讲,原料药涨价,但制剂价格受限制不能上涨,有可能亏本甚至停产,中国近九千药品面临成本危机 the price of APIs has risen, but the price of preparations in China cannot be rised due to restrictions, It may be at a loss or even stop production. Nearly 9,000 drugs (preparations) in China are facing a cost crisis.

Norfloxacin [CAS#70458-96-7]

Norfloxacin

  • CAS NO. 70458-96-7 
  • Category: API 
  • Standard: BP/USP
  • Certificate: DML/GMP, no DMF 
  • Appearance: white or pale yellow crystalline powder
  • Usage: Norfloxacin is an antibiotic in a group of drugs called fluoroquinolones (flor-o-KWIN-o-lones). Norfloxacin fights bacteria in the body. Norfloxacin is used to treat different bacterial infections of the prostate or urinary tract (bladder and kidneys). Norfloxacin is also used to treat gonorrhea.
ITEM STANDARD
Description White to pale yellow crystalline powder
Identification Shall comply with USP38 test A and B
Loss on drying ≤1.0%
Residue on ignition ≤0.1%
Heavy metals ≤0.0015%
Purity chromatographic The sum of all impurities peaks is not more than 0.5%
Assay 99.0% ~ 101.0%
  • Packing: 25kgs/drum
  • Shelf life: 5 years
  • Transportation & Storage: Keep in dry, cool and ventilating places. It is a non-dangerous product and can be transported as a common chemical product. Avoid direct sunlight and rain.

Methyl Salicylate [CAS#119-36-8]

Methyl Salicylate

  • CAS No. 119-36-8
  • Category: API
  • Standard: BP2016
  • Certificate: DML/cGMP
  • Usage: It is used in high concentrations as a rubefacient and analgesic in deep heating liniments (such as Bengay) to treat joint and muscular pain
Main Items Specifications
Characters A colorless or slightly yellow liquid, very slightly soluble in water, miscible with alcohol and with fatty and essential oils
Identification – A A crystalline precipitate is formed and melts 156℃ to 161℃
Identification – B A violet-red color developed
Appearance of solution The solution is clear and not more colored than reference solution Y7
Acidity 0.1M NaOH not more than 0.4ml
Refractive index 1.535 – 1.538
Specific gravity 1.180 – 1.186
Assay Contains C8H8O3 99.0% – 100.5%
Conclusion Conforms to BP2016
  • Packing: 25kgs/drum
  • Shelf life: 3 years
  • Transportation & Storage: Keep in dry, cool and ventilating places. It is a non-dangerous product and can be transported as a common chemical product. Avoid direct sunlight and rain.

Clotrimazole [CAS#23593-75-1]

Clotrimazole

  • CAS NO. 23593-75-1
  • Category: API
  • Standard: BP/EP/USP
  • Certificate: DML/GMP/DMF
  • Appearance: White crystalline powder
  • Usage: Clotrimazole is used to treat yeast infections of the vagina, mouth, and skin such as athlete’s foot, jock itch, and body ringworm. It can also be used to prevent oral thrush in certain patients.
Main Items Specifications
Related compound A NMT0.2%
Melting point 141℃ – 145℃
Imidazole NMT0.5%
Loss on drying NMT0.5%
Residue on Ignition NMT0.1%
Heavy metals NMT0.001%
Assay 98% – 102%
Benzene NMT2ppm
TPC NMT1000cfu/g
Conclusion Conforms with BP/EP/USP
  • Packing: 25kgs/drum
  • Shelf life: 2 years
  • Transportation & Storage: Keep in dry, cool and ventilating places. It is a non-dangerous product and can be transported as a common chemical product. Avoid direct sunlight and rain.