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     Black Pepper Capsules contain an amount of powdered Black Pepper equivalent to not
less than 90.0 per cent and not more than 110.0 per cent of the labelled content of
alkaloids, calculated as piperine (C₁₇H₁₉NO₃), and not less than 80.0 per cent of the
labelled amount of volatile oil, calculated on the anhydrous basis.
Strength available 250 mg (powder).
Dose One to two capsules three times a day after meals.
Packaging and storage Black Pepper Capsules shall be kept in well-closed containers,
protected from light, and stored in a dry place at a temperature not exceeding 30°.
Labelling The label on the container states (1) the equivalent amount of alkaloid as piperine;
(2) the amount of volatile oil; (3) the expiration date.
Identification

     A. The capsle contents exhibit diagnostic structures of the powdered drug described
under Black Pepper.
     B. The capsule contents comply with the tests for Identification A, B, and C described
under Black Pepper.
Water Of the capsule contents, not more than 14.0 per cent v/w (Azeotropic Distillation
Method, Appendix 4.12)
Microbial limit Comply with the requirements for Category 4 in the “Limits for Microbial
Contamination” (Appendix 10.5).
Assay
FOR VOLATILE OIL Remove, as completely as possible, the contents of not less than
20 Black Pepper Capsules, mix, and transfer about 50 g, accurately weighed, to a 500-mL
round-bottomed flask. Use 250 mL of water as the distillation liquid and distil at a rate of
2 to 3 mL per minute for 5 hours. Use 2.0 mL of xylene in the graduated tube (Appendix 7.3H).
Calculate the content of volatile oil, in mL, in the portion of the Capsules taken with
reference to the anhydrous substance.
FOR PIPERINE Carry out the determination as described in the “Ultraviolet and Visible
Spectrophotometry” (Appendix 2.2).
     Standard piperine solution Transfer about 20 mg of piperine, accurately weighed, into
a 100-mL volumetric flask, add chloroform to dissolve, and dilute to volume.
     Standard piperine curve Transfer into five 25-mL volumetric flasks 0.2 mL, 0.4 mL,
0.6 mL, 0.8 mL, and 1.0 mL, respectively, of Standard piperine solution and add chloroform to make
1.0 mL. To each flask add 10.0 mL of chromotropic acid TS, shake vigorously and place in
a water-bath for 30 minutes. Set aside for a few minutes, stopper, and allow to cool. Then add
10 mL of dilute sulfuric acid, mix well, allow to cool, and dilute with sufficient dilute sulfuric
acid to volume. Measure the absorbances of the piperine-containing solutions relative to the
blank at 570 nm (Appendix 2.2). Plot the readings and draw the curve of best fit.

     Procedure Weigh and mix the contents of not less than 20 Black Pepper Capsules. Grind
to No. 150 powder and transfer about 500 mg, accurately weighed, in an extraction thimble
and insert the thimble into a soxhlet extractor of appropriate size. Moisten with 0.5 mL of
chloroform, mix, allow to stand for about 5 minutes, make alkaline with 0.5 mL of ammonia TS,
and mix. Macerate for 6 to 12 hours or overnight, cover with a pledget of absorbent cotton,
add a sufficient quantity of chloroform, and extract until complete extraction of the alkaloids
is effected (Appendix 7.4). Transfer the total mass to a 250-mL volumetric flask, dilute with
chloroform to volume and filter. Transfer 1.0 mL of the filtrate to a 25-mL volumetric flask,
and proceed as directed under Standard piperine curve, beginning with “Add 10.0 mL of
chromotropic acid TS, ...”. Read the absorbance of the resulting solution, and by reference to
the Standard piperine curve, calculate the content of alkaloids as piperine (C₁₇H₁₉NO₃) in the
portion of the Capsules taken.
Other requirements Comply with the requirements described under “Capsules” (Appendix
1.16H).