Pregn-4-ene-3,20-dione,11,17,21-trihydroxy-,(11β)-cortisol [50-23-7]
质量标准:
美国药典25版
鉴别:符合规定
A: 红外吸收
B: 紫外吸收
比旋度:+150°~ +156°
干燥失重 ≤ 1.0 %
灼烧残渣:可以忽略
层析杂质:
单个杂质≤0.5%
总杂质≤2.0%
有机挥发杂质: 符合要求
含量: 97%~102%
Quality standard:
USP25
Identification:
A: Infrared Absorption
B: Ultraviolet Absorption
Specific rotation :between +150°and +156°
Loss on drying:≤ 1.0 %
Residue on ignition: negligible from 100mg
Chromatographic Purity:
Individual purity≤0.5%
Total purity≤2.0%
Organic volatile impurities: meets the requirements
Assay: 97%~102%
Pregn-4-ene-3,20-dione,21-(acetyloxy)-11,17-dihydroxy-,(11β)-
Cortisol 21-acetate [50-03-3]
质量标准:
美国药典25版
鉴别:符合规定
A: 红外吸收
B: 紫外吸收
比旋度:+158°~ +165°
干燥失重 ≤ 1.0 %
灼烧残渣:可以忽略
层析杂质:
单个杂质≤1.0%
总杂质≤2.0%
含量: 97%~102%
Quality standard:
USP25
Identification:
A: Infrared Absorption
B: Ultraviolet Absorption
Specific rotation :between +158°and +165°
Loss on drying:≤ 1.0 %
Residue on ignition: negligible from 100mg
Chromatographic Purity:
Individual purity≤1.0%
Total purity≤2.0%
Assay: 97%~102%
C22H24N2O8·HCl·1/2C2H6O·1/2H2O 512.9 [24390-14-5]
质量标准:
英国药典2000版
性状:黄色结晶粉末
PH值:2.0~3.0
比旋度:-105°~ -120°
吸光率:349nm下300~335
杂质光吸收:490nm下≤0.07
相关杂质:
乙醇:4.3~6.0
重金属:≤50ppm
水分:1.4%~2.8%
硫酸盐灰烬:≤0.4%
细菌内毒素:≤1.14 I.U./mg
Quality standard:
BP2000
Characters: A yellow crystalline powder
PH: 2.0~3.0
Specific optical rotation : -105°~ -120°
Absorbance: 300~335@349nm
Light-absorbing impurities: ≤0.07@490nm
Related substances
Ethanol: 4.3~6.0
Heavy metals: ≤50ppm
Water: 1.4%~2.8%
Sulphated ash: ≤0.4%
Bacterial endotoxins: ≤1.14 I.U./mg
4-(Dimethylamino)-1,4,4a,5,5a, 6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy
-6- methlene- 1, 11 -dioxo- 2 - naphthacennecarboxamide monohydrochoride. [3963-95-9]
质量标准:
英国药典2000版
鉴别:紫外吸收
结晶度:符合要求
PH值:2.0~3.0
水分:≤ 2.0%
效价:每毫克效价=832~970μg土霉素
Quality standard:
BP2000
Identification: Ultraviolet Absorption
Crystallinity: meets the requirements
PH: 2.0~3.0
Water: ≤ 2.0%
Potency: equivalent to 832~970μg Methacycline per mg
18,19-Dinorpregn-4-en-20-yn-3-one,13-ethyl-17-hydroxy-,(17α)-(-)-(-)-13-
Ethyl-17-hydroxy-18,19-dinoxr-17α-pregn-4-en-20-yn-3-one [797-63-7]
质量标准:
美国药典25版
鉴别:符合规定
A: 红外吸收
熔程:232℃~ 239℃
比旋度:-30°~ -35°
干燥失重 ≤ 0.5 %
灼烧残渣:≤0.3%
乙炔化合物限度:7.81%~8.18%
层析杂质:
单个杂质≤0.5%
总杂质≤2.0%
含量: 98%~102%
Quality standard:
USP25
Identification:
A: Infrared Absorption
Melting range: 232℃~ 239℃
Specific rotation: between -30°and -35°
Loss on drying:≤0.5 %
Residue on ignition:≤0.3%
Limit of ethynyl group: 7.81%~8.18%
Chromatographic purity:
Single impurity≤0.5%
Sum of impurities≤2.0%
Assay: 98%~102%
3,5-pyrinedicarboxylic acid 4-(2,3-dichlorophenyl)-1,4-dihydro-2,6-dimethyl-
ethyl methyl ester,(±)-(±)-ethylmethyl 4-(2,3-dichlorophenyl)-1,4-dihydro-2,6-
dimethyl-3,5-pyridinedicarboxylate [72509-76-386189-69-7]
质量标准:
美国药典25版
鉴别:符合规定
A: 红外吸收
干燥失重:≤0.5 %
灼烧残渣:≤0.1%
重金属:0.002%
层析杂质:
单个杂质≤1.0%
总杂质≤1.5%
含量: 98%~101%
Quality standard:
USP25
Identification:
A: Infrared Absorption
Loss on drying:≤0.5 %
Residue on ignition:≤0.1%
Heavy metal: 0.002%
Chromatographic Purity:
Individual purity≤1.0%
Total purity≤1.5%
Assay: 98%~101%
4-pyridinecarboxylic acid, hydrazide. Isonicotinic acid hydrazide [54-85-3]
质量标准:
美国药典25版
鉴别:符合规定
A: 红外吸收
熔程:170℃~ 173℃
PH值:6.0~7.5
干燥失重 ≤ 1.0%
灼烧残渣:≤0.2%
重金属:0.002%
有机挥发杂质:符合要求
含量: 98%~102%
Quality standard:
USP25
Identification:
A: Infrared Absorption
Melting range: 170℃~ 173℃
PH: 6.0~7.5
Loss on drying:≤ 1.0%
Residue on ignition:≤0.2%
Heavy metal: 0.002%
Organic volatile impurities: meets the requirements
Assay: 98%~102%
质量标准: 国家药品监督管理局 Quality standard: S.D.A. of China
WS-10001-(HD-0226)-2002 WS-10001-(HD-0226)-2002
性状:黄色、黄绿色或浅棕黄色粉末 Characters: A yellow green-yellow or light brown powder
其他羟乙基衍生物:峰面积之和≤20% Other ramifications: Sum of Peak Area≤20%
PH值:5.0 ~ 7.0 PH: 5.0 ~ 7.0
水分:≤ 4.0% Water: ≤ 4.0%
灼烧残渣:≤ 2.5% Residue on ignition: ≤ 2.5%
重金属:≤ 20ppm Heavy Metals: ≤ 20ppm
含量:≥80% Assay: ≥80%
质量标准: Quality standard:
中国卫生部94部颁标准 STANDARD OF THE HEALTH MINISTRY OF CHINA(94)
性状:白色或类白色粉末 DESCRIPTION: A WHITE CRYSTALLINE POWDER
熔点:151-154℃ MELTING POINT: 151-154℃
溶液外观:无色透明 SOLUTION CLEARLY: CLEAR
干燥失重:≤0.5% LOSS ON DRYING: ≤0.5%
炽灼残渣:≤0.1% RESIDUE ON IGNITION:≤0.1%
重金属:≤20 ppm HEAVY METALS: ≤20 ppm
酸度:5.0 - 7.0 PH: 5.0 - 7.0
含量:≥ 99.0% ASSAY: ≥ 99.0%
Pregna-2,4-dien-20-yno[2,3-d]isoxazol-17-ol,(17α)-17α-pregna-2,4-dien-20-
yno[2,3-d]isoxazol-17-ol [17230-88-5]
质量标准: Quality standard:
美国药典27版 USP 27
鉴别:符合规定 Identification:
A: 红外吸收 A: Infrared Absorption
B: 紫外吸收 B: Ultraviolet Absorption
比旋度:+21°~ +27° Specific rotation: between +21°and +27°
干燥失重: ≤ 2.0 % Loss on drying: ≤ 2.0 %
层析杂质: Chromatographic Purity:
单个杂质: ≤0.5% Individual purity: ≤0.5%
总杂质: ≤1.0% Total purity: ≤1.0%
含量: 97%~102% Assay: 97%~102%