Bot Detector
IJPC Seal
Download FREE Sample Issue or Article
LEARN MORE
Subscribe Today
A subscription to IJPC provides on-line access to full-text, full-color, printable PDF copies of your subscribed issues, individual articles, and purchased archives.

Long-term Stability of Cocaine Hydrochloride Aqueous Solution 50 mg/mL (5%) at Room Temperature and at 5°C ± 3°C in Glass Bottles

Author(s):  Dewulf Joseph, Hecq Jean-Daniel, Huvelle Sophie, Godet Marie, Gillet Patricia, Jamart Jacques, Galanti Laurence M

Issue:  May/Jun 2015 - Volume 19, Number 3
View All Articles in Issue

Page(s):  268-270

Long-term Stability of Cocaine Hydrochloride Aqueous Solution 50 mg/mL (5%) at Room Temperature and at 5°C ± 3°C in Glass Bottles Page 1
Long-term Stability of Cocaine Hydrochloride Aqueous Solution 50 mg/mL (5%) at Room Temperature and at 5°C ± 3°C in Glass Bottles Page 2
Long-term Stability of Cocaine Hydrochloride Aqueous Solution 50 mg/mL (5%) at Room Temperature and at 5°C ± 3°C in Glass Bottles Page 3

Download in electronic PDF format for $75

Abstract:  The objective of this study was to investigate the stability of cocaine hydrochloride 50 mg/mL (5%) aqueous solution stored in glass bottles at 5°C ± 3°C or at room temperature. Ten bottles of cocaine hydrochloride 50 mg/mL were prepared under aseptic conditions. Five were stored at 5°C ± 3°C and five at room temperature. pH measurements, optic density measurements at different wavelengths, and optic microscopic observations were performed periodically during the storage. A forced-degradation test with hydrochloric acid 12M and NaOH 5M with and without heating at 100°C was also performed. The concentrations were measured by high-pressure liquid chromatography with photodiode-array detection. Stability of the solutions was defined as the period for which the onesided 95% confidence interval of the common regression line remains superior to 90% of the initial concentration as recommended by the U.S. Food and Drug Administration. The forced-degradation tests did not influence the chromatographic peaks of the studied component. No significant change of optic density was seen and no crystals were observed with the optic microscope during the study. The solutions stored at 5°C ± 3°C or at room temperature maintained 90% of their concentration after 24 days. During this period, the pH of the solution decreased from 5.39 to 4.34 at 5°C ± 3°C and from 5.37 to 3.44 at room temperature. In order to alleviate adverse reactions to the eye with too low pH, we propose a period of validity of 15 days at 5°C ± 3°C and 48 hours at room temperature. During this period, the degradation of the preparation was lower than 10%, and the values of pH were higher than 4.0.

Related Keywords: Joseph Dewulf, PharmD, Jean-Daniel Hecq, PharmD, PhD, Sophie Huvelle, PharmD, Marie Godet, BSc, PhD, Patricia Gillet, PharmD, Jacques Jamart, MD, MSc, Laurence M. Galanti, MD, PhD, cocaine hydrochloride aqueous solution, stabilty, storage temperature, local anesthetic, minor surgery, corneal epithelium debridement

Related Categories: PACKAGING, PAIN MANAGEMENT, PEER-REVIEWED, STABILITIES, COMPATIBILITIES, NEUROLOGY, STORAGE

Printer-Friendly Version



Related Articles from IJPC
Title/Author
(Click for Abstract / Details / Purchase)
Issue/​Page
View/Buy
Long-term Stability of Cocaine Hydrochloride Aqueous Solution 50 mg/mL (5%) at Room Temperature and at 5°C ± 3°C in Glass Bottles
Dewulf Joseph
, Hecq Jean-Daniel, Huvelle Sophie, Godet Marie, Gillet Patricia, Jamart Jacques, Galanti Laurence M
May/Jun 2015
Pg. 268-270

Long-term Stability of Vancomycin Hydrochloride in Oral Solution: The Brand Name Versus a Generic Product
Huvelle Sophie
, Godet Marie, Hecq Jean-Daniel, Gillet Patricia, Jamart Jacques, Galanti Laurence M
Jul/Aug 2016
Pg. 347-350

Long-term Stability of Esomeprazole in 5% Dextrose Infusion Polyolefin Bags at 5°C ± 3°C after Microwave Freeze-thaw Treatment
Hecq Jean-Daniel
, Rolin Catherine, Godet Marie, Gillet Patricia, Jamart Jacques, Galanti Laurence M
Nov/Dec 2015
Pg. 521-524

Long-term Stability of Vancomycin Hydrochloride in Glucose 5% Polyolefin Bags: The Brand Name Versus a Generic Product
Huvelle Sophie
, Godet Marie, Hecq Jean-Daniel, Gillet Patricia, Jamart Jacques, Galanti Laurence M
Sep/Oct 2016
Pg. 416-420

Long-term Stability of Morphine Hydrochloride in 0.9% NaCl Infusion Polyolefin Bags After Freeze-thaw Treatment and in Polypropylene Syringes at 5°C ± 3°C
Hecq J-D
, Godet M, Gillet P, Jamart J, Galanti L
Jan/Feb 2014
Pg. 78-82

Stability Studies of Fludrocortisone Acetate Capsules and Fludrocortisone Acetate Titrated Powders (Powder Triturates)
Brandin Thibaut
, Wasilewski Maya, Panuccio Camille, Bouguergour Cyrielle, Primas Nicolas, Lamy Edouard, Jean Christophe, Bertault-Peres Pierre, Rathelot Pascal, Curti Christophe, Vanelle Patrice
Mar/Apr 2022
Pg. 150-154

Incorporating Quality Assurance in Pharmaceutical Compounding-related Courses in the PharmD Curricula
Hossain Mohammad Faisal
, Levesque Dan, Frye John, Rashid Mamoon
Jul/Aug 2020
Pg. 322-326

Long-term Physicochemical Stability of Concentrated Solutions of Isosorbide Dinitrate in Polypropylene Syringes for Administration in the Intensive Care Unit
Lardinois Benjamin
, Dimitriou Alexandre, Delcave Charlotte, Soumoy Laura, Jamart Jacques, Bihin Benoît, Hecq Jean-Daniel, Galanti Laurence M
Jan/Feb 2020
Pg. 64-68

Long-term Physiochemical Stability of Concentrated Solutions of Salbutamol (Albuterol) in Polypropylene Syringes for Use in the Intensive Care Unit and in Obstetrics
Lardinois Benjamin
, Baltzis Alexandre, Delcave Charlotte, Soumoy Laura, Jamart Jacques, Bihin Benoît, Hecq Jean-Daniel, Galanti Laurence
Sep/Oct 2019
Pg. 434-437

Stability of Ribavirin for Inhalation Packaged in Syringes or Glass Vials when Stored Frozen, Refrigerated, and at Room Temperature
Larson Bayli
, Bushman Lane R, Casciano Matthew L, Oldland Alan R, Kiser Jennifer J, Kiser Tyree H
Nov/Dec 2016
Pg. 521-525

Compounding for Diabetic Patients:An Interview with Paul Lofholm, PharmD
Allen Loyd V Jr
Nov/Dec 1997
Pg. 381-385

Compounding in the Pharmacy Curriculum: Beyond the Basics
Hinkle Amanda R
, Newton Gail D
May/Jun 2004
Pg. 181-185

Long-term Physicochemical Stability of Concentrated Solutions of Sodium Valproate in Polypropylene Syringes for Administration in the Intensive Care Unit
Lardinois Benjamin
, Baltzis Alexandre, Braibant Maximilien, Soumoy Laura, Jamart Jacques, Bihin Benoît, Hecq Jean-Daniel, Galanti Laurence
Jul/Aug 2019
Pg. 320-323

Long-term Physicochemical Stability of Concentrated Solutions of Noradrenaline Bitartrate in Polypropylene Syringes for Administration in the Intensive Care Unit
Lardinois Benjamin
, Pector Johan, Delcave Charlotte, Soumoy Laura, Jamart Jacques, Bihin B, Hecq Jean-Daniel, Galanti Laurence M
Jul/Aug 2018
Pg. 335-339

Comparative Stability of Vitamin K1 Oral Liquids Prepared in Sterile Water for Injection and Stored in Amber Glass Bottles and Amber Plastic Syringes
Huffman Jessica
, Brown Stacy, Lewis Paul, Lawson Sarah, Ogle Amanda, Peacock Gina
Jul/Aug 2018
Pg. 340-344

Stability of Extemporaneously Prepared Hydroxycarbamide Oral Suspensions
Kabiche Djamila
, Balde Issa-Bella, Majoul Elyes, Kabiche Sofiane, Bourguignon Elodie, Fontan Jean-Eudes, Cisternino Salvatore, Schlatter Joel
Mar/Apr 2017
Pg. 160-163

Stability of Lidocaine Hydrochloride Injection at Ambient Temperature and 4°C in Polypropylene Syringes
Storms Meredith L
, Stewart James T, Warren Flynn W
Sep/Oct 2002
Pg. 388-390

Evaluation of the Physicochemical Stability of Amiodarone Hydrochloride in Syringes for the Intensive Care Unit
Lardinois Benjamin
, Dimitriou Alexandre, Delcave Charlotte, Jamart Jacques, Bihin Benoît, Soumoy Laura, Hecq Jean-Daniel, Galanti Laurence M
Mar/Apr 2019
Pg. 163-166

Finding the Right Balance: A Nationwide Study of Student Pharmacist Exposure to and Perceptions of Nonsterile Compounding
Fredrickson Mary E
, Belcher Faith G, Del Vecchio Kamryn N, Galleher Miranda N, Jugo Leila S, Gothard M David, Pallotta Raneem H, Pallotta Victor A Jr
May/Jun 2022
Pg. 242-247

Effect of Freezing, Long-Term Storage and Microwave Thawing on the Stability of Tramadol in 5% Dextrose Infusion in Polyvinyl Chloride Bags
Lebrun John
, Hecq Jean-Daniel, Vanbeckbergen Danielle, Jamart Jacques, Galanti Laurence M
Mar/Apr 2004
Pg. 156-159

Return to Top