chloramphenicol

product Name

chloroamphenicol

Synonyms

chloramphenicol; 2,2-dichloro-n-[2-hydroxy-1-(hydroxymethyl)-2-(4-nitrophenyl)ethyl]acetamide; d-(-)-threo-2,2-dichloro-n-[beta-hydroxy-alpha-(hydroxy-methyl)-p-nitrophenethyl]acetamide; chloromycetin; 2,2-dichloro-N-[(1R,2S)-1,3-dihydroxy-1-(4-nitrophenyl)propan-2-yl]acetamide; 2,2-dichloro-N-[(1S,2R)-1,3-dihydroxy-1-(4-nitrophenyl)propan-2-yl]acetamide; 2,2-dichloro-N-[(1R)-2-hydroxy-1-(hydroxymethyl)-2-(4-nitrophenyl)ethyl]acetamide; 2,2-dichloro-n-(2-hydroxy-1-(hydroxymethyl)-2-(4-nitrophenyl)ethyl)-acetamid

Molecular Formula

C₁₁H₁₂Cl₂N₂O₅

Molecular Weight

323.1294

InChI

InChI=1/C11H12Cl2N2O5/c12-10(13)11(18)14-8(5-16)9(17)6-1-3-7(4-2-6)15(19)20/h1-4,8-10,16-17H,5H2,(H,14,18)/t8-,9/m1/s1

CAS Registry Number

56-75-7

EINECS

200-287-4

Molecular Structure

Density

1.547g/cm³

Melting point

149-153℃

Boiling point

644.9°C at 760 mmHg

Refractive index

1.611

Flash point

343.8°C

Water solubility

2.5 g/L (25℃)

Vapour Pressure

1.63E-17mmHg at 25°C

Hazard Symbols

T:Toxic;

Risk Codes

R45:;

Safety Description

S45:;
S53:;

Item

Standard

Results

Appearance

A white, greyish-white or yellowish-white, fine, crystalline powder or fine crystals

White, fine, crystalline powder

Assay

Chloramphenicol contains not less than 97 percent and not more than 103.0 percent of C₁₁H₁₂Cl₂N₂O₅

99.4%

Identification

IR

Complies

The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation

Complies

Melting range

149°~ 153 °

151.2°~ 152°

Specific Rotation

+17° ~ +20.0°

+19.3°

Crystallinity

Meets the requirements

Conforms

Bacterial endotoxins

Meets the requirements

Conforms

Sterility

Meets the requirements

Conforms

pH

4.5~7.5

5.3

Chromatographic purity

Meet the requirements

Conforms

Conclusion

The products is complies with respect to USP32

Item

Standard

Results

Characters

Appearance

A white, greyish-white or yellowish-white, fine, crystalline powder or fine crystals

White, fine, crystalline powder

Solubility

Slightly soluble in water, freely soluble in alcohol and in propylene glycol. A solution in ethanol is dextrorotatory and a solution in ethyl acetate is laevorotatory.

Complies

Assay

Chloramphenicol contains not less than 98 percent and not more than 102.0 percent of C₁₁H₁₂Cl₂N₂O_5， calculated with reference to the dried substance

99.4%

Identification

Melting point: 149 ℃ to 153 ℃

150.3℃ ~ 151.2 ℃

IR: Correspond with the Chloramphenicol CRS

Complies

The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation

Complies

Acidity or alkalinity(pH)

5.0~7.5

5.3

Specific optical Rotation

+18.5° ~ +20.5°

+19.3°

Related substances

Any spot:≤0.5%

Conforms

Chlorides

Not more than 100ppm

＜50ppm

Loss on drying

Not more than 0.5%

0.20%

Sulphated ash

Not more than 0.1%

0.06%

Pyrogens

Meet the requirement

Conforms

Conclusion

The products is complies with respect to BP2009