Stability and Expiry Date of Remedies

Summary

Expiry date and stability testing are relatively new concepts in homeopathy. There is a lack of scientific data regarding the evaluation of expiry dates of homeopathic tinctures and potencies. This is a preliminary work in that direction, where we have tried to develop standard methodology for stability testing. Nicotiana tabacum tincture (77 % alcohol) was subjected to various tests as per WHO and ICH guidelines and introduced new criteria of evaluating the biological efficacy by in vitro culture studies for the samples, which are five to ten years old.

Key words

Shelf life - Stability - Expiry date - Homeopathic tinctures - ICH - WHO Guidelines

• References

• 1 Gupta A. Shelf life of ayurvedic dosage forms. Indian J Traditional Knowledge 2011; 10: 672-677
• 2 Guidelines on stability testing: stability testing of existing active substances and related finished products. European Medicines Agency Inspections 2003; 122: 1-18 (CPMP/QWP) 02, rev 1 corr
• 3 Chitra S. Comparative phytochemical analysis of tobacco and its natural extract. Int J Pharm Pharm Sci 2012; 4 (Suppl. 02) S1-S2
• 4 Official Method, Tobacco Control Programme, Determination of Alkaloid in Whole Tobacco (T- 301). Ottawa, Canada: Health Canada; 1999: 1-10
• 5 Piade JJ, Hoffman D. Chemical studies on tobacco smoke LXVII. J Liq Chrom Relat Tech 1980; 3: 1505-1515
• 6 Ruan Chun Sheng. Study on ultra violet visible spectral feature of tobacco leaves by pattern recognition. J Life Sci 2009; 3: 34-53 serial no. 22
• 7 Tabacum monograph. Homoeopathic Pharmacopeia of India 1971; 1: 197
• 8 Nicotine U.V. absorption. Homoeopathic Pharmacopeia of India 1990; 6: 207 Appendix (xxx)