美国药典-中英文对照(翻译资料)

W

为供试液中辣椒

素含 量，单位为

mg

，

ru

为供试液中其它辣椒二萜类化合物而非辣椒素、二氢辣

椒素峰面积之和，

rs

为对照液中辣椒素峰面积。

其它辣椒二萜 类化合物总百分含

量不超过

15

％。< /p>

C18H27NO3 305.41

6-Nonenamide,

(E)-N-[(4-Hydroxy-3-methoxy- phenyl)methyl]-8-methyl.

(E)-8-Methyl- N-vanillyl-6-nonenamide [404-86-4].

Capsaicin contains not less than 90.0 percent and not more than 110.0

percent of the labeled percentage of total content of

capsaicin (C18H27NO3) is not less than 55 percent, and the sum of the

contents of capsaicin and dihydrocapsaicin (C18H29NO3) is not less than 75

percent, and the content of other capsaicinoids is not more than 15 percent, all

calculated on the dried basis.

Caution

——

Handle Capsaicin with care. Prevent inhalation of particles of it and

prevent its contact with any part of the body.

Packaging and storage

——

Preserve in tight containers, protected from

light, and store in a cool place.

Labeling

——

Label it to state the percentage content of total

capsaicinoids.

USP Reference standards

〈

11

〉

——

USP Capsaicin RS. USP

Dihydrocapsaicin RS.

Identification

——

Prepare a test solution of Capsaicin in methanol

containing l mg per mL. Prepare a Standard solution of USP Capsaicin RS in

methanol containing l mg per mL. Separately apply 10 -

礚

portions of the test

solution and the Standard solution to a thin-layer chromatographic plate(see

Chromatography

〈

2 1

〉

)coated with a 0.25-mm layer of chromatographic silica

gel mixture. Develop the chromatograms in a solvent system consisting of a

mixture of ether and methanol (19:1) until the solvent front has moved about

threefourths of the length of the plate. Remove the plate from the chamber,

and allow it to air-dry. Spray the plate with a 0.5% solution of

2,6-dibromoquinone-chlorimide in methanol, allow to stand in a chamber

containing ammonia fumes, and examine the chromatograms:the blue color

and the R value of the principal spot obtained from the test solution correspond

to those properties of the principal spot obtained from the Standard solution.

Melting range

〈

741

〉

: between 57°and 66°, but the range between

beginning and end of melting does not exceed 5°.

Loss on drying

〈

731

〉

: Dry it in vacuum over phosphorus pentoxide at

40°for 5 hours: it loses not more than 1.0% of its weight.

Residue on ig nition

〈

281

〉

: not more than 1.0%.

Content of capsaicin, dihydrocapsaicin, and other capsaicinoids

—

Mobile

phase

—

Prepare a mixture of diluted phosphoric acid (l in 1000) and acetonitrile

(600:400). Filter through a filter having a porosity of 0.5

祄

or finer, and degas.

Make adjustments if necessary (see System Suitability under Chromatography

〈

621

〉

).

Standard dihydrocapsaicin solution

—

Dissolve an accurately weighed

quantity of USP Capsaicin RS quantitatively in methanol to obtain a solution

having a known concentration of about 0.1 mg per mL.

Standard dihydrocapsaicin solution

—

Dissolve an accurately weighed quantity

of USP Dihydrocapsaicin RS quantitatively in methanol to obtain a solution

having a known concentration of about 0.025 mg per mL.

Test solution

—

Transfer about 25 mg of Capsaicin, accurately weighed, to a

250-mL volumetric flask, dilute with methanol to volume, and mix.

Chromatographic system (see Chromatogra phy

〈

621

〉

)

—

The liquid

chromatograph is equipped with a 281-nm detector and a 4.6-mm x 25-cm

column that contains 5-

μm packi

ng L11 and is maintained at a constant

temperature of about 30°. Adjust the flow rate to obtain a retention time of

about 20 minutes for the main capsaicin peak. Chromatograph the Standard

capsaicin solution, and record the peak responses as directed for procedure:

the relative standard deviation for replicate injections is not more than 2%.

Procedure

—Separately inject equal volunes (about 20 μL) of the

Standard capsaicin solution, the Standard dihydrocapsaicin solution, and the

Test solution into the chromatograph, record the chromatogram for a period of

time that is twice that of the retention time of capsaicin, and measure the areas

of the responses for all of the peaks. Calculate the percentage of capsaicin

(C18H27NO3) in the portion of Capsaicin taken by the formula:

25,000(C/W)(gu/gs),

in which C is the concentration, in mg per mL, of USP Capsaicin RS in

the Standard capsaicin solution, W is the weight, in mg, of Capsaicin taken to

prepare the Test solution, and ru and rs are the capsaicin peak responses

obtained from the Test solution, and the Standard ate the percentage of

dihydrocapsaicin (C18H29NO3) in the portion of Capsaicin taken by the formula:

25,000(C/W)(gu/gs),

in which C is the concentration, in mg per mL, of USP Dihydrocapsaicin

RS in the Standard capsaicin solution, W is the weight, in mg, of Capsaicin

taken to prepare the Test solution, and ru and rs are the dihydrocapsaicin peak

responses obtained from the Test solution and the Standard dihydrocapsaicin

solution, respectively. The sum of the percentage of capsaicin found and of the

percentage of dihydrocapsaicin found is not less than 75%. Using the

chromatograms obtained from the Standard capsaicin solution and the Test

solution, calculate the percentage of other capsaicinoids in the portion of

Capsaicin taken by the formula:

25,000(C/W)(gu/gs),

in which C is the concentration, in mg per mL, of USP Capsaicin RS in

the, W is the weight, in mg, of Capsaicin taken to prepare the Test solution, rT

is the sum of the peak responses of the capsaicinoids other than capsaicin and

dihydrocapsaicin in the chromatogram obtained from the Test solution, and rs

is the capsaicin peak response obtained from the Standard capsaicin solution.

Not more than 15% of other capsaicinoids is found.

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本帖最后由

tinalongding

于

2008-12-8 17:24

编辑

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2008-12-8 17:23

tinalongding

Papain

Papain [9001-73-4]

Papain is a purified proteolytic substance derived from Carica papaya

Linné(ceae).papain,when assayed directed herein, contains not less

than 6000 units per mg. Papain of a higher digestive power may be reduced to