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          Hog Creeper Vine Dry Extract Capsules are prepared from Hog Creeper Vine Dry Extract and contain not less than 90.0 per cent and not more than 110.0 per cent of the labelled amount of genistein-7-O-[α-rhamnopyranosyl-(1^_→6)-β-glucopyranoside], calculated as genistein (C₁₅H₁₀O₅). 

Strength available  400 mg of hog creeper vine dry extract. 

Dose  Lower back pain and knee osteoarthritis: 400 mg twice a day immediately after meals. 

Contra-indication  It is contra-indicated in pregnant women. 

Warning 

1.  It should be used with caution in patients with peptic ulcer.    

2.  It may cause gastro-intestinal irritation, stomachache ,constipation,frequent urination, thirst, or palpitation.       

3.  Long-term use should be avoided. 

Packaging and storage Hog Creeper Vine Dry Extract Capsules shall be kept in tightly closed containers, protected from light, and stored at the temperature not exceeding 30°. 

Labelling  The label on the container states (1) the equivalent amount of genistein -7-O- [α-rhamnopyranosyl-(1^_→6)-β-glucopyranoside], calculated as genistein; (2)  expiration date. 

Identification

       A.  The chromatogram of the Assay preparation shows several peaks, one of which
corresponds to that of the Standard preparation, as obtained in the Assay.         

       B.  The capsules contents comply with the tests for Identification A and B described under Hog Creeper Vine Dry Extract.  

Microbial limit  Comply with the requirements for Category 1A in the “Limits for Microbial Contamination” (Appendix 10.5). 

Assay  Carry out the test as described in the “Liquid Chromatography” (Appendix 3.5). 

      Mobile phase A, Mobile phase B, Standard preparation, Chromatographic system, and Procedure  Proceed as directed in the Assay under Hog Creeper Vine Dry Extract. 

      Assay preparation  Remove, as completely as possible, the contents of not less than  20  Hog Creeper Vine Dry Extract Capsules.  Transfer an accurately weighed portion of the capsule contents, containing about 500 mg of hog creeper vine dry extract, to a 200-mL volumetric flask.  Add 150 mL of ethanol (50 per cent), sonicate for 30 minutes, dilute to volume, and mix.  Transfer 5.0 mL of this solution to a 10-mL volumetric flask, dilute with the same solvent  to volume, mix, and filter. 

       Calculation  Calculate the content of genistein-7-O-[α-rhamnopyranosyl-(1^_→6)-β-glucopyranoside], calculated as genistein, in the portion of the Capsules taken, using  the declared content of C₁₅H₁₀O₅ in Genistein RS. 

       Other requirements  Comply with the requirements described under “Capsules”  (Appendix 1.16H).