A Novel Stability Study of Simvastatin Generic Tablet in Public Pharmacy Facilities of Purwakarta District, Indonesia
Keywords:
Drug stability, simvastatin, storage conditions, pharmacy facilities
Abstract
Drug stability is one of the most important criteria for producing safe, excellent and effective products. Some environmental factors that influence drug stability are light, temperature, and humidity. Simvastatin is a cholesterol-lowering drug that is known to be sensitive to high temperature and humidity. The purpose of this study is to analyze the effect of 6 months of real-time storage conditions on the stability of generic simvastatin tablets in public pharmacy facilities. This study used simulation method with 4 brands of simvastatin generic tablets with two different strengths (10 mg and 20 mg). In the process, the sample was conditioned in 6 different regions for 6 months. The results of temperature and humidity monitoring showed 2 locations at ≤ 25 ° C, 4 locations had a temperature of ≥ 25 °C and all locations had humidity > 65 %. The drug was evaluated for physical and chemical quality parameters at months 0, 3, and 6. After being stored for 6 months, the tablets showed a decrease in disintegration time and an increase in the friability, showing lack of durability. Similarly, there was a decrease in the content concentration in the tablets but fortunately the level was still within the accepted specification range (90 – 110 %). However, there was one tablet that did not meet the dissolution test requirements after the storage duration (Q ≤ 75 % at 30 minutes). The results of the stress test showed that simvastatin degraded in all conditions. This stress test confirmed the extreme instability of simvastatin. Poor storage conditions can reduce the quality of generic simvastatin tablets, thus a well-controlled environment is vital in pharmacy facilities.
References
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Akbuga, J., & Gürsoy, A. (1987). The Effect of Moisture Sorption and Desorption on Furosemide Tablet Properties. Drug Dev. Indus. Pharm., 13(9-11), 1827-1845. https://doi.org/10.3109/03639048709068695
Allen, L. V., Jr. (2013). Basics of compounding: potency and stability testing. Int. J. Pharm. Compd., 17(3), 220-224.
Allinson, J. G., Dansereau, R. J., & Sakr, A. (2001). The effects of packaging on the stability of a moisture sensitive compound. Int. J. Pharm., 221(1-2), 49-56. https://doi.org/10.1016/s0378-5173(01)00670-6
Ammann, C. (2011). Stability studies needed to define the handling and transport conditions of sensitive pharmaceutical or biotechnological products. AAPS PharmSciTech, 12(4), 1264-1275. https://doi.org/10.1208/s12249-011-9684-0
ASEAN. (2017). ASEAN Guidelines nn Stability Study and Shelf-Life of Traditional Medicines. The Association of Southeast Asian Nations (ASEAN). Retrieved 09/09/2021 from https://asean.org/wp-content/uploads/2017/09/ASEAN-Guidelines-on-Stability-and-Shelf-Life-TM-V1.0-with-disclaimer.pdf
Bajaj, S., Singla, D., & akhuja, N. S. (2012). Stability Testing of Pharmaceutical Products. J. Appl. Pharmaceu. Sci., 02(03), 129-138. https://doi.org/10.7324/JAPS.2012.2322
Bakre, L., & Taiwo, Y. (2015). Studies of the effect of storage conditions on some Pharmaceutical Parameters of Pharmaceutical Powders and Tablets. Dhaka Univ. J. Pharmaceu. Sci., 14(2), 147-151. https://doi.org/10.3329/dujps.v14i2.28503
Bharath Raman, H. M., Patrick Ball. (2017). Pharmaceuticals in the tropics: A quantitative study measuring changes in quantity of the active ingredient and microbiological growth. J. Appl. Pharmaceu. Sci.(9), 160-170. http://japsonline.com/abstract.php?article_id=2420
BIO Intelligence Service, B. (2013). Study on the environmental risks of medicinal products (Final Report prepared for Executive Agency for Health and Consumers, Issue. https://ec.europa.eu/health/sites/default/files/files/environment/study_environment.pdf
Bott, R. F., & Oliveira, W. P. (2007). Storage conditions for stability testing of pharmaceuticals in hot and humid regions. Drug. Dev. Ind. Pharm., 33(4), 393-401. https://doi.org/10.1080/03639040600975022
Chaturvedi, H., Garg, A., & US., R. (2017). Post-compression evaluation parameters for tablets-an overview. Eur. J. Pharm. Med. Res., 37(1), 526–530.
Chen, W. L., Guo, D. W., Shen, Y. Y., Guo, S. R., & Ruan, K. P. (2012). Effects of highly hygroscopic excipients on the hydrolysis of simvastatin in tablet at high relative humidity. Indian J. Pharm. Sci., 74(6), 527-534. https://doi.org/10.4103/0250-474x.110587
Chiang, E. (2013). Measuring Tablet Hardness: A Primer. Pharm. Technol., 37(1), 1–3.
Devu, S., Gupta, A., Srinivas, K., Gupta, R., & Semwal, V. (2012). Chromatography Development and Validation of Stability Indicating RP-UPLC Method for Simultaneous Determination in Fixed Dose Combination of Ezetimibe and. J. Chromatogr. Sep. Tech. , 3(1), 1–7.
Dugar, R. P., Gupta, P., & Dave, R. H. (2015). Effect of relative humidity on acetaminophen tablet properties prepared by different techniques using polyvinylpyrrolidine derivatives as binder. Inter. J. Pharmaceu. Sci. Res., 6(11), 4629.
Farmakope, N. F. a. D. A. (2014). Farmakope Indonesia (Vol. 5). National Food and Drug Agency.
FDA. (2005). ASEAN guideline on stability study of drug product. In a. c. c. f. s. a. q.-p. p. w. g. (ACCSQ-PPWG) (Ed.). Jakarta: FDA.
Gupta, M. M., & Gupta, M. (2016). Comparative In-Vitro Quality Control Testing of Different Brands of Paracetamol Tablets Available In The Trinidad & Tobago, West Indies. Int. J. Pharm. Sci .Res., 2830-2836.
Hapsari, Y. (2016). Quality Comparison of simvastatin tablets BPJS e-catalogue and non BPJS e-catalogue [Thesis, UIN]. Jakarta. https://repository.uinjkt.ac.id/dspace/bitstream/123456789/33426/1/Yunnica%20Sri%20Hapsari-FKIK.pdf
Jemal, M., Ouyang, Z., & Powell, M. L. (2000). Direct-injection LC-MS-MS method for high-throughput simultaneous quantitation of simvastatin and simvastatin acid in human plasma. J. Pharm. Biomed. Anal., 23(2-3), 323-340. https://doi.org/10.1016/s0731-7085(00)00309-5
Kapuganti, A., Gandhi, B., Raju, V., Sumanth, K., Kagitapurapu, V., Srinivas, K., & Harika, P. (2016). Development and Validation of Stability Indicating RP-HPLC Method for Simultaneous Estimation of Ramipril, Aspirin and Simvastatin in Bulk and Pharmaceutical Dosage Form. Asian J. Biomed. Pharm. Sci., 6(1), 14-20.
Karbane, M., Ramli, Y., Al-Kamarany, M., Bouchfra, H., Radi, M., Karrouchi, K., Cherrah, Y., Bouklouze, A., & Azougagh, M. (2014). Development and validation of HPLC dissolution assay of simvastatin tablets under normal and accelerated conditions. J. . Chem. Pharmaceu. Res., 6(6), 886-893.
Khan, M. H., Hatanaka, K., Sovannarith, T., Nivanna, N., Casas, L. C. C., Yoshida, N., Tsuboi, H., Tanimoto, T., & Kimura, K. (2013). Effects of packaging and storage conditions on the quality of amoxicillin-clavulanic acid - an analysis of Cambodian samples. BMC Pharmacol. Toxicol., 14, 33-33. https://doi.org/10.1186/2050-6511-14-33
Kumar, D. A., Sujan, D. P., Vijayasree, V., & Rao, J. V. L. N. S. (2009). Simultaneous Determination of Simvastatin and Ezetimibe in Tablets by HPLC. E-Journal Chem., 6, 626343. https://doi.org/10.1155/2009/626343
Lehto, V. P., & Erling, I. (2007). An effective desiccant system to regulate the humidity inside the chambers of the solid dosage forms. Drug. Dev. Ind. Pharm., 33(11), 1233-1239. https://doi.org/10.1080/03639040701377946
Lotfy, H. M., El Sanabary, H. F., El-Sherif, Z. A., & El-Bardicy, M. G. (2010). Stability study of simvastatin and pravastatin sodiumunder acidic hydrolytic conditions assessed by high performance liquid chromatography. Anal. Chem: An Ind. Journal, 9(1), 172-184.
Markl, D., & Zeitler, J. A. (2017). A Review of Disintegration Mechanisms and Measurement Techniques. Pharmaceu. Res., 34(5), 890-917. https://doi.org/10.1007/s11095-017-2129-z
Markman, B. E., Rosa, P. C., & Koschtschak, M. R. (2010). Assessment of the quality of simvastatin capsules from compounding pharmacies. Rev. Saude Publica, 44(6), 1055-1062. https://doi.org/10.1590/s0034-89102010000600010
Marques-Marinho, F., José da Costa Zanon, C., Sakurai, E., Reis, I. A., Lima, A. A., & Vianna-Soares, C. D. (2011). Quality evaluation of simvastatin compounded capsules. Brazilian J. Pharm. Sci., 47(3), 495–502. https://doi.org/10.1590/S1984-82502011000300007
Melo, S. R., Homem-de-Mello, M., Silveira, D., & Simeoni, L. A. (2014). Advice on Degradation Products in Pharmaceuticals: A Toxicological Evaluation. PDA J. Pharm. Sci. Tech., 68(3), 221-238. https://doi.org/10.5731/pdajpst.2014.00974
Mubengayi, C. K., Ramli, Y., Routaboul, C., Gilard, V., El Karbane, M., Cherrah, Y., MaletMartino, M., & Essassi, E. M. (2016). Quality Evaluation of Diclofenac Formulations Manufactured in DR Congo. Pharm. Anal. Chem., 2(1), 1-6. https://doi.org/10.4172/2471-2698.1000112
Nayyar, G. M. L., Breman, J. G., Newton, P. N., & Herrington, J. (2012). Poor-quality antimalarial drugs in southeast Asia and sub-Saharan Africa. The Lancet Infect. Dis., 12(6), 488-496. https://doi.org/10.1016/S1473-3099(12)70064-6
Nogueira, F. H., Moreira-Campos, L. M., Santos, R. L., & Pianetti, G. A. (2011). Quality of essential drugs in tropical countries: evaluation of antimalarial drugs in the Brazilian Health System. Rev. Soc. Bras. Med. Trop., 44(5), 582-586. https://doi.org/10.1590/s0037-86822011000500010
Othman, G., & Al-qadasi, F. (2016). Quality and Stability of Amoxicillin-Potassium Clavulanate Drugs Marketed in Yemen: Influence of Tropical Storage Conditions. J. Chem. Pharmaceu. Res., 8, 160-166.
Ramalingam, P., Bhaskar, V. U., Reddy, Y. P., & Kumar, K. V. (2014). Stability-indicating RP-HPLC Method for the Simultaneous Determination of Sitagliptin and Simvastatin in Tablets. Ind. J. Pharmaceu. Sci., 76(5), 407-414. https://pubmed.ncbi.nlm.nih.gov/25425754
Rubinstein, M. H., & Bodey, D. M. (1976). Disaggregation of Compressed Tablets. J. Pharmaceu. Sci., 65(12), 1749-1753. https://doi.org/https://doi.org/10.1002/jps.2600651214
Seitz, J. A., & Flessland, G. M. (1965). Evaluation of the physical properties of compressed tablets. I. Tablet hardness and friability. J. Pharmaceu. Sci., 54(9), 1353-1357. https://doi.org/10.1002/jps.2600540926
Shafaat, K., Hussain, A., Kumar, B., Hasan, R., Prabhat, P., & Yadav, V. (2013). An Overview: Storage of Pharmacuetical Products. World J. Pharm. Phramaceu. Sci, 2, 2499-2515.
Singh, A., Sharma, P., & Malviya, R. (2011). Eco Friendly Pharmaceutical Packaging Material. World Appl. Sci. J., 14, 1703-1716.
Tembhare, E., Gupta, K. R., & Umekar, M. J. (2019). An Approach to Drug Stability Studies and Shelf-life Determination. . Arch. Curr. Res. Inter., 19(1), 1-20. https://doi.org/10.9734/acri/2019/v19i130147
Twagirumukiza, M., Cosijns, A., Pringels, E., Remon, J. P., Vervaet, C., & Van Bortel, L. (2009). Influence of tropical climate conditions on the quality of antihypertensive drugs from Rwandan pharmacies. Am. J. Trop. Med. Hyg., 81(5), 776-781. https://doi.org/10.4269/ajtmh.2009.09-0109
USP. (2006). Material Safety Data Sheet Simvastatin Tablets. In USP (Ed.). New York: USP.
USP, U. S. P. t. e. (2011). The United States Pharmacopeial Convention. USP. Retrieved 03/09/2019 from https://www.usp.org/sites/default/files/usp/document/harmonization/gen-method/stage_6_monograph_25_feb_2011.pdf
Waterman, K., & MacDonald, B. (2010). ChemInform Abstract: Package Selection for Moisture Protection for Solid, Oral Drug Products. J. Pharmaceu. Sci., 99, 4437-4452. https://doi.org/10.1002/jps.22161
Waterman, K. C., & MacDonald, B. C. (2010). Package selection for moisture protection for solid, oral drug products. J. Pharmaceu. Sci., 99(11), 4437-4452. https://doi.org/10.1002/jps.22161
World Health, O., & Preparations, W. H. O. E. C. o. S. f. P. (2018a). Fifty-second report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations. World Health Organization. https://apps.who.int/iris/handle/10665/272452
World Health, O., & Preparations, W. H. O. E. C. o. S. f. P. (2018b). Guide to good storage practices for pharmaceuticals. World Health Organization. https://apps.who.int/iris/handle/10665/272452
Akbuga, J., & Gürsoy, A. (1987). The Effect of Moisture Sorption and Desorption on Furosemide Tablet Properties. Drug Dev. Indus. Pharm., 13(9-11), 1827-1845. https://doi.org/10.3109/03639048709068695
Allen, L. V., Jr. (2013). Basics of compounding: potency and stability testing. Int. J. Pharm. Compd., 17(3), 220-224.
Allinson, J. G., Dansereau, R. J., & Sakr, A. (2001). The effects of packaging on the stability of a moisture sensitive compound. Int. J. Pharm., 221(1-2), 49-56. https://doi.org/10.1016/s0378-5173(01)00670-6
Ammann, C. (2011). Stability studies needed to define the handling and transport conditions of sensitive pharmaceutical or biotechnological products. AAPS PharmSciTech, 12(4), 1264-1275. https://doi.org/10.1208/s12249-011-9684-0
ASEAN. (2017). ASEAN Guidelines nn Stability Study and Shelf-Life of Traditional Medicines. The Association of Southeast Asian Nations (ASEAN). Retrieved 09/09/2021 from https://asean.org/wp-content/uploads/2017/09/ASEAN-Guidelines-on-Stability-and-Shelf-Life-TM-V1.0-with-disclaimer.pdf
Bajaj, S., Singla, D., & akhuja, N. S. (2012). Stability Testing of Pharmaceutical Products. J. Appl. Pharmaceu. Sci., 02(03), 129-138. https://doi.org/10.7324/JAPS.2012.2322
Bakre, L., & Taiwo, Y. (2015). Studies of the effect of storage conditions on some Pharmaceutical Parameters of Pharmaceutical Powders and Tablets. Dhaka Univ. J. Pharmaceu. Sci., 14(2), 147-151. https://doi.org/10.3329/dujps.v14i2.28503
Bharath Raman, H. M., Patrick Ball. (2017). Pharmaceuticals in the tropics: A quantitative study measuring changes in quantity of the active ingredient and microbiological growth. J. Appl. Pharmaceu. Sci.(9), 160-170. http://japsonline.com/abstract.php?article_id=2420
BIO Intelligence Service, B. (2013). Study on the environmental risks of medicinal products (Final Report prepared for Executive Agency for Health and Consumers, Issue. https://ec.europa.eu/health/sites/default/files/files/environment/study_environment.pdf
Bott, R. F., & Oliveira, W. P. (2007). Storage conditions for stability testing of pharmaceuticals in hot and humid regions. Drug. Dev. Ind. Pharm., 33(4), 393-401. https://doi.org/10.1080/03639040600975022
Chaturvedi, H., Garg, A., & US., R. (2017). Post-compression evaluation parameters for tablets-an overview. Eur. J. Pharm. Med. Res., 37(1), 526–530.
Chen, W. L., Guo, D. W., Shen, Y. Y., Guo, S. R., & Ruan, K. P. (2012). Effects of highly hygroscopic excipients on the hydrolysis of simvastatin in tablet at high relative humidity. Indian J. Pharm. Sci., 74(6), 527-534. https://doi.org/10.4103/0250-474x.110587
Chiang, E. (2013). Measuring Tablet Hardness: A Primer. Pharm. Technol., 37(1), 1–3.
Devu, S., Gupta, A., Srinivas, K., Gupta, R., & Semwal, V. (2012). Chromatography Development and Validation of Stability Indicating RP-UPLC Method for Simultaneous Determination in Fixed Dose Combination of Ezetimibe and. J. Chromatogr. Sep. Tech. , 3(1), 1–7.
Dugar, R. P., Gupta, P., & Dave, R. H. (2015). Effect of relative humidity on acetaminophen tablet properties prepared by different techniques using polyvinylpyrrolidine derivatives as binder. Inter. J. Pharmaceu. Sci. Res., 6(11), 4629.
Farmakope, N. F. a. D. A. (2014). Farmakope Indonesia (Vol. 5). National Food and Drug Agency.
FDA. (2005). ASEAN guideline on stability study of drug product. In a. c. c. f. s. a. q.-p. p. w. g. (ACCSQ-PPWG) (Ed.). Jakarta: FDA.
Gupta, M. M., & Gupta, M. (2016). Comparative In-Vitro Quality Control Testing of Different Brands of Paracetamol Tablets Available In The Trinidad & Tobago, West Indies. Int. J. Pharm. Sci .Res., 2830-2836.
Hapsari, Y. (2016). Quality Comparison of simvastatin tablets BPJS e-catalogue and non BPJS e-catalogue [Thesis, UIN]. Jakarta. https://repository.uinjkt.ac.id/dspace/bitstream/123456789/33426/1/Yunnica%20Sri%20Hapsari-FKIK.pdf
Jemal, M., Ouyang, Z., & Powell, M. L. (2000). Direct-injection LC-MS-MS method for high-throughput simultaneous quantitation of simvastatin and simvastatin acid in human plasma. J. Pharm. Biomed. Anal., 23(2-3), 323-340. https://doi.org/10.1016/s0731-7085(00)00309-5
Kapuganti, A., Gandhi, B., Raju, V., Sumanth, K., Kagitapurapu, V., Srinivas, K., & Harika, P. (2016). Development and Validation of Stability Indicating RP-HPLC Method for Simultaneous Estimation of Ramipril, Aspirin and Simvastatin in Bulk and Pharmaceutical Dosage Form. Asian J. Biomed. Pharm. Sci., 6(1), 14-20.
Karbane, M., Ramli, Y., Al-Kamarany, M., Bouchfra, H., Radi, M., Karrouchi, K., Cherrah, Y., Bouklouze, A., & Azougagh, M. (2014). Development and validation of HPLC dissolution assay of simvastatin tablets under normal and accelerated conditions. J. . Chem. Pharmaceu. Res., 6(6), 886-893.
Khan, M. H., Hatanaka, K., Sovannarith, T., Nivanna, N., Casas, L. C. C., Yoshida, N., Tsuboi, H., Tanimoto, T., & Kimura, K. (2013). Effects of packaging and storage conditions on the quality of amoxicillin-clavulanic acid - an analysis of Cambodian samples. BMC Pharmacol. Toxicol., 14, 33-33. https://doi.org/10.1186/2050-6511-14-33
Kumar, D. A., Sujan, D. P., Vijayasree, V., & Rao, J. V. L. N. S. (2009). Simultaneous Determination of Simvastatin and Ezetimibe in Tablets by HPLC. E-Journal Chem., 6, 626343. https://doi.org/10.1155/2009/626343
Lehto, V. P., & Erling, I. (2007). An effective desiccant system to regulate the humidity inside the chambers of the solid dosage forms. Drug. Dev. Ind. Pharm., 33(11), 1233-1239. https://doi.org/10.1080/03639040701377946
Lotfy, H. M., El Sanabary, H. F., El-Sherif, Z. A., & El-Bardicy, M. G. (2010). Stability study of simvastatin and pravastatin sodiumunder acidic hydrolytic conditions assessed by high performance liquid chromatography. Anal. Chem: An Ind. Journal, 9(1), 172-184.
Markl, D., & Zeitler, J. A. (2017). A Review of Disintegration Mechanisms and Measurement Techniques. Pharmaceu. Res., 34(5), 890-917. https://doi.org/10.1007/s11095-017-2129-z
Markman, B. E., Rosa, P. C., & Koschtschak, M. R. (2010). Assessment of the quality of simvastatin capsules from compounding pharmacies. Rev. Saude Publica, 44(6), 1055-1062. https://doi.org/10.1590/s0034-89102010000600010
Marques-Marinho, F., José da Costa Zanon, C., Sakurai, E., Reis, I. A., Lima, A. A., & Vianna-Soares, C. D. (2011). Quality evaluation of simvastatin compounded capsules. Brazilian J. Pharm. Sci., 47(3), 495–502. https://doi.org/10.1590/S1984-82502011000300007
Melo, S. R., Homem-de-Mello, M., Silveira, D., & Simeoni, L. A. (2014). Advice on Degradation Products in Pharmaceuticals: A Toxicological Evaluation. PDA J. Pharm. Sci. Tech., 68(3), 221-238. https://doi.org/10.5731/pdajpst.2014.00974
Mubengayi, C. K., Ramli, Y., Routaboul, C., Gilard, V., El Karbane, M., Cherrah, Y., MaletMartino, M., & Essassi, E. M. (2016). Quality Evaluation of Diclofenac Formulations Manufactured in DR Congo. Pharm. Anal. Chem., 2(1), 1-6. https://doi.org/10.4172/2471-2698.1000112
Nayyar, G. M. L., Breman, J. G., Newton, P. N., & Herrington, J. (2012). Poor-quality antimalarial drugs in southeast Asia and sub-Saharan Africa. The Lancet Infect. Dis., 12(6), 488-496. https://doi.org/10.1016/S1473-3099(12)70064-6
Nogueira, F. H., Moreira-Campos, L. M., Santos, R. L., & Pianetti, G. A. (2011). Quality of essential drugs in tropical countries: evaluation of antimalarial drugs in the Brazilian Health System. Rev. Soc. Bras. Med. Trop., 44(5), 582-586. https://doi.org/10.1590/s0037-86822011000500010
Othman, G., & Al-qadasi, F. (2016). Quality and Stability of Amoxicillin-Potassium Clavulanate Drugs Marketed in Yemen: Influence of Tropical Storage Conditions. J. Chem. Pharmaceu. Res., 8, 160-166.
Ramalingam, P., Bhaskar, V. U., Reddy, Y. P., & Kumar, K. V. (2014). Stability-indicating RP-HPLC Method for the Simultaneous Determination of Sitagliptin and Simvastatin in Tablets. Ind. J. Pharmaceu. Sci., 76(5), 407-414. https://pubmed.ncbi.nlm.nih.gov/25425754
Rubinstein, M. H., & Bodey, D. M. (1976). Disaggregation of Compressed Tablets. J. Pharmaceu. Sci., 65(12), 1749-1753. https://doi.org/https://doi.org/10.1002/jps.2600651214
Seitz, J. A., & Flessland, G. M. (1965). Evaluation of the physical properties of compressed tablets. I. Tablet hardness and friability. J. Pharmaceu. Sci., 54(9), 1353-1357. https://doi.org/10.1002/jps.2600540926
Shafaat, K., Hussain, A., Kumar, B., Hasan, R., Prabhat, P., & Yadav, V. (2013). An Overview: Storage of Pharmacuetical Products. World J. Pharm. Phramaceu. Sci, 2, 2499-2515.
Singh, A., Sharma, P., & Malviya, R. (2011). Eco Friendly Pharmaceutical Packaging Material. World Appl. Sci. J., 14, 1703-1716.
Tembhare, E., Gupta, K. R., & Umekar, M. J. (2019). An Approach to Drug Stability Studies and Shelf-life Determination. . Arch. Curr. Res. Inter., 19(1), 1-20. https://doi.org/10.9734/acri/2019/v19i130147
Twagirumukiza, M., Cosijns, A., Pringels, E., Remon, J. P., Vervaet, C., & Van Bortel, L. (2009). Influence of tropical climate conditions on the quality of antihypertensive drugs from Rwandan pharmacies. Am. J. Trop. Med. Hyg., 81(5), 776-781. https://doi.org/10.4269/ajtmh.2009.09-0109
USP. (2006). Material Safety Data Sheet Simvastatin Tablets. In USP (Ed.). New York: USP.
USP, U. S. P. t. e. (2011). The United States Pharmacopeial Convention. USP. Retrieved 03/09/2019 from https://www.usp.org/sites/default/files/usp/document/harmonization/gen-method/stage_6_monograph_25_feb_2011.pdf
Waterman, K., & MacDonald, B. (2010). ChemInform Abstract: Package Selection for Moisture Protection for Solid, Oral Drug Products. J. Pharmaceu. Sci., 99, 4437-4452. https://doi.org/10.1002/jps.22161
Waterman, K. C., & MacDonald, B. C. (2010). Package selection for moisture protection for solid, oral drug products. J. Pharmaceu. Sci., 99(11), 4437-4452. https://doi.org/10.1002/jps.22161
World Health, O., & Preparations, W. H. O. E. C. o. S. f. P. (2018a). Fifty-second report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations. World Health Organization. https://apps.who.int/iris/handle/10665/272452
World Health, O., & Preparations, W. H. O. E. C. o. S. f. P. (2018b). Guide to good storage practices for pharmaceuticals. World Health Organization. https://apps.who.int/iris/handle/10665/272452
Published
2021-12-31
How to Cite
Yulianita, R., Sopyan, I., Mohd Gazzali, A., & Muchtaridi, M. (2021). A Novel Stability Study of Simvastatin Generic Tablet in Public Pharmacy Facilities of Purwakarta District, Indonesia. Indonesian Journal of Pharmacy, 32(4), 548-562. https://doi.org/10.22146/ijp.2730
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Section
Research Article
