上海弘邦医药科技有限公司

Product: 5-Aminolevulinic Acid Methyl Ester HCL

  CAS#:  79416-27-6

Item

Inspection Standard

Appearance

A white or off-white powder

Melting point

115.0~125℃

Heavy Metals(Pb)

≤ 20ppm

Loss on Drying

≤ 1.0%

Residue on Ignition

≤ 0.5%

Becteria endotoxins

≤ 0.4USP EU / mg

Total aerobic microbital count

≤100 cfu/g

Impurities

Any other single impurity

≤ 1.0%

Total impurities

≤ 2.0%

Assay

≥ 98.0%

Product: 5-Aminolevulinic acid HCL(pharma grade)

CAS#:  5451-09-2

Item

Inspection Standard

Appearance

Almost white to off-white powder

Melting point

150.0℃～155 ℃

Heavy Metals(Pb)

≤ 20ppm

Iron(Fe)

≤ 20ppm

Loss on Drying

≤ 1.0%

Residue on Ignition

≤ 0.5%

Bacteria endotoxins

≤ 0.4 USP EU/mg

Micronial

limits

Total arerobic microbial count

≤  100 cfu/g

Staphylococcus aureus

Absence

Pseudomonas aeruginosa

Absence

Salmonella species

Absence

Escherichia coli

Absence

Any other single impurity

≤ 0.3%

Total impurity

≤ 1.0%

Assay( HPLC)

98.0%~102.0%

检验项目

Item

检验标准

Inspection Standard

外  观

Appearance

白色结晶或结晶性粉末；溶于水，易溶于乙醇，难溶于乙醚

White crystals or crystalline powder; it is very soluble in water, freely soluble in ethanol, and practially insoluble in diethyl ether.

鉴别

Identification

(1)(2)(3)(4)应符合规定

(1)(2)(3)(4) should be conform to standards

PH

4.5~5.5

熔点  Melting point

90 ~ 93℃

溶液的澄清度和颜色

Clarity and color of solution

溶液应澄清无色

The solution is clear and colorless

重金属  Heavy metals

≤10 ppm

砷   Arsenic

≤2ppm

有关物质

Related substances

应符合规定

Should be conform to standards

干燥失重Loss on drying

≤ 0.3%

炽灼残渣Residue on ignition

≤ 0.1%

含量    Assay

≥98.0%