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%