Betamethasone

Betamethasone

Details
1.Cas No.: 378-44-9
2. Appearance: White to almost white,odorless, crystalline powder
3. Assay:100%
4. Molecular Formula: C22H29FO5
5. Molecular Weight: 434.50
Category
Active Pharmaceutical Ingredients
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Description
Technical Parameters

Betamethasone

Betamethasone is an adrenal cortical hormone drug and an isomer of dexamethasone. It has the same effect as prednisolone and dexamethasone, and is mainly used for allergic and autoimmune inflammatory diseases. It is now mostly used for active rheumatism, rheumatoid arthritis, lupus erythematosus, severe bronchial asthma, severe dermatitis, etc., and is also used for the comprehensive treatment of certain infections.
It has multiple pharmacological effects such as anti-inflammatory, anti-rheumatic, anti-allergic and immunosuppressive. The anti-inflammatory effect is stronger than dexamethasone, triamcinolone, hydrocortisone, etc. It can reduce and prevent the tissue's response to inflammation, eliminate the fever, redness and swelling caused by local non-infectious inflammation, thereby reducing the manifestations of inflammation.

Betamethasone

ITEMS

SPECIFICATIONS

RESULTS

Appearance

White to almost white,odorless, crystalline powder

Conforms

Identification

Complies with the stanard

Conforms

Loss on drying

≤0.5%

0.08 %

Residue on Ignition

≤0.3%

0.3%

Specific on rotation

+118~ +126.

+ 123.4 °

Melting point

50 ℃ ~ 60 ℃

50 ℃ ~ 60 ℃

Sulphate ash

≤0.1%

0.05%

Heavy metals

≤ 20 ppm

< 20ppm

Related substance

Total impurity ≤2.0%

Single impurity ≤.20%

0.41%

0.12%

Methanol

≤ 3000 ppm

Conforms

Ethylacetate

≤ 3000 ppm

Conforms

DMF

≤ 3000 ppm

Conforms

Acetone

≤ 3000 ppm

Conforms

Dichlormethane

≤ 3000 ppm

Conforms

Assay

97.0~103.0%

100.0 %

Conclusiion

This product complied with the standard of EP 6.0

Betamethasone

The Cochrane Database of Systematic Reviews compared betamethasone and dexamethasone for fetal lung maturation in pregnant women at risk of preterm birth.
Dosage regimen: betamethasone 12mg, im, qd, 2d and dexamethasone 6mg, im, bid, 2d.
The results showed that betamethasone was superior to dexamethasone in reducing perinatal mortality, bronchopulmonary development, reducing neonatal sepsis, necrotizing enterocolitis, and reducing neonatal ICU admission rates.
The anti-inflammatory effect of betamethasone is stronger than that of dexamethasone, and a smaller dose is required to achieve an equivalent anti-inflammatory effect.
Betamethasone is safer.
Betamethasone has less effect on patients' blood sugar.

Betamethasone

Betamethasone injection, cream.

Reference

[1].Antignac JP, Le Bizec B, Monteau F, Andre F (January 2002). "Differentiation of betamethasone and dexamethasone using liquid chromatography/positive electrospray tandem mass spectrometry and multivariate statistical analysis". Journal of Mass Spectrometry. 37 (1): 69–75. Bibcode:2002JMSp...37...69A. doi:10.1002/jms.260. PMID 11813313.

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