Stability testing for hot and humid climates

WHO Drug Information

Volumn 18, Issue 2, 2004, Pages 113-116

  Slamet, Lucky S ^a   Jaafar, Hjh Siti Mariam Hj Md ^b  

^a Natl Agy of Drug and Food Control   (Indonesia)

^b Ministry of Health   (Brunei Darussalam)

Author keywords

[No Author keywords available]

Indexed keywords

DRUG;

CALCULATION; CLIMATE; COST; DRUG PACKAGING; DRUG STABILITY; DRUG STORAGE; HUMIDITY; PRACTICE GUIDELINE; QUALITY CONTROL; REVIEW; SOUTHEAST ASIA; TEMPERATURE; VAPOR PRESSURE; WORLD HEALTH ORGANIZATION;

EID: 4344693314     PISSN: 10109609     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (6)

1. World Health Organization. Expert Committee on Specifications for Pharmaceutical Preparations. Technical Report Series, No. 863 Annex 5, (1996) on: http://www.who.int/medicines/strategy/quality_safety/annex5_trs863.doc
2. World Health Organization. WHO guidelines for stability testing of pharmaceutical products containing well-established drug substances in conventional dosage forms. http://www.who.int/medicines/qsm and in: WHO Drug Information, 16(1): 35, (2002), on http://www.who.int/druginformation/ vol16num1_2002/161table_of_contents.shtml
3. World Health Organization. Expert Committee on Specifications for Pharmaceutical Preparations. Thirty-seventh report. Technical Report Series, No 908, p.13 (2003).
4. International Conference on Harmonization. Guidelines Q1A and Q1F. http://www.ich.org/
5. World Health Organization. Expert Committee on Specifications for Pharmaceutical Preparations. Technical Report Series, No. 863 table 2, page 70 (1996) on: http://www.who.int/medicines/strategy/quality_safety/annex5_trs863. doc
6. Kennon, L., Use of models in determining chemical pharmaceutical stability. Journal of Pharmaceutical Sciences. 53(7): 815-818 (1964).