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Demeclocycline Capsules contain Demeclocycline Hydrochloride.
The capsules comply with the requirements stated under Capsules and with the following requirements.
Content of demeclocycline hydrochloride, C21H21ClN2O8,HCl
|90.0 to 107.0% of the stated amount.|
A. Carry out the method for thin-layer chromatography, Appendix III A, using silica gel H as the coating substance and a mixture of 6 volumes of water, 35 volumes of methanol and 59 volumes of dichloromethane as the mobile phase. Adjust the pH of a 10% w/v solution of disodium edetate to 7.0 with 10m sodium hydroxide and spray the solution evenly onto the plate (about 10 ml for a plate 100 mm × 200 mm). Allow the plate to dry in a horizontal position for at least 1 hour. At the time of use, dry the plate in an oven at 110° for 1 hour. Apply separately to the plate 1 µl of each of the following solutions. For solution (1) extract a quantity of the contents of the capsules containing 10 mg of demeclocycline hydrochloride with 20 ml of methanol and centrifuge. Solution (2) contains 0.05% w/v of demeclocycline hydrochloride BPCRS in methanol. Solution (3) contains 0.05% w/v each of demeclocycline hydrochloride BPCRS, oxytetracycline hydrochloride BPCRS and metacycline hydrochloride EPCRS in methanol. Allow the plate to dry in a stream of air and examine under ultraviolet light (365 nm). The principal spot in the chromatogram obtained with solution (1) corresponds to that in the chromatogram obtained with solution (2). The test is not valid unless the chromatogram obtained with solution (3) shows three clearly separated spots.
B. Add 20 ml of warm methanol to a quantity of the contents of the capsules containing 10 mg of demeclocycline hydrochloride, allow to stand for 20 minutes, filter and evaporate the filtrate to dryness on a water bath. To 0.5 mg of the residue add 2 ml of sulphuric acid; a purple colour is produced. Add 1 ml of water; the colour changes to yellow.
C. To 1 mg of the residue obtained in test B add 7 ml of water and 7 ml of 2m hydrochloric acid and heat gently for 30 seconds. No colour is produced immediately.
Comply with the requirements for Monographs of the British Pharmacopoeia in the dissolution test for tablets and capsules, Appendix XII B1, using Apparatus 2. Use as the medium 900 ml of 0.1m hydrochloric acid and rotate the paddle at 50 revolutions per minute. Withdraw a sample of 10 ml of the medium and filter. Carry out the method for liquid chromatography, Appendix III D, using the following solutions. For solution (1) dilute the filtered solution, if necessary, with 0.1m hydrochloric acid to give a solution expected to contain about 0.015% w/v of demeclocycline hydrochloride. Solution (2) contains 0.015% w/v of demeclocycline hydrochloride BPCRS in 0.1m hydrochloric acid.
The chromatographic procedure may be carried out using (a) a stainless steel column (25 cm × 4.6 mm) packed with octadecylsilyl silica gel for chromatography (5 µm) (Lichrosorb RP18 is suitable) and maintained at 40°, (b) as the mobile phase with a flow rate of 2 ml per minute a mixture of 20 volumes of dimethylformamide and 80 volumes of 0.1m oxalic acid the pH of which has been adjusted to 2.2 with triethylamine and (c) a detection wavelength of 355 nm.
Calculate the total content of demeclocycline hydrochloride, C21H21ClN2O8,HCl, in the medium using the declared content of C21H21ClN2O8,HCl, in demeclocycline hydrochloride BPCRS.
Carry out the method for liquid chromatography, Appendix III D, using solutions (1) and (3) described under Assay.
The chromatographic conditions described under Dissolution may be used.
The area of any secondary peak in the chromatogram obtained with solution (1) is not greater than the area of the principal peak in the chromatogram obtained with solution (3) (10%) and the sum of the areas of any secondary peaks is not greater than 1.5 times the area of the principal peak in the chromatogram obtained with solution (3) (15%).
Loss on drying
When dried at 60° at a pressure not exceeding 0.7 kPa for 3 hours, the contents of the capsules lose not more than 5.0% of their weight. Use 1 g.
Carry out the method for liquid chromatography, Appendix III D, using the following solutions. For solution (1) mix a quantity of the mixed contents of 20 capsules containing 0.5 g of demeclocycline hydrochloride with 50 ml of 0.01m hydrochloric acid, add sufficient 0.01m hydrochloric acid to produce 100 ml, filter and dilute 1 volume of the filtrate to 5 volumes with 0.01m hydrochloric acid. Solution (2) contains 0.10% w/v of demeclocycline hydrochloride BPCRS in 0.01m hydrochloric acid. Solution (3) contains 0.010% w/v of demeclocycline hydrochloride BPCRS in 0.01m hydrochloric acid. Solution (4) contains 0.015% w/v each of demeclocycline hydrochloride BPCRS and 4-epidemeclocycline hydrochloride EPCRS in 0.01m hydrochloric acid.
The chromatographic conditions described under Dissolution may be used.
The assay is not valid unless the resolution factor between the two principal peaks in the chromatogram obtained with solution (4) is at least 3.0.
Calculate the content of C21H21ClN2O8,HCl in the capsules using the declared content of C21H21ClN2O8,HCl in demeclocycline hydrochloride BPCRS.
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Dideu Industries is one of the largest producer for general chemical, pharmaceutical, nutrition additive, natural extracts, agrochemical and Daily-Use Chemical in China and is headquartered in Shaanxi, China. The Dideu Group comprises subsidiaries and joint ventures in more than 10 countries and operates six integrated production sites and 21 other production sites in Europe, Asia, Australia, Americas and Africa.Its headquarters is located in Xi’An,China. Dideu has customers in over 200 countries and supplies products to a wide variety of industries.
At the end of 2014, the company employed more than 13000 people. In 2014, Group Dideu posted sales of 30 billion and income from operations before special items of about 7.5 billion. The company is currently expanding its international activities with a particular focus on Asia countries. Between 1990 and 2005, the company invested 5.2 billion in Asia, for example in sites near Guangxi,Yunnan, Sichuan, Shaanxi China,Mangalore in India,Bangkok, Thailand,Hanoi, Vietnam etc.
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At Dideu, we redefine chemistry to make the world better - and have been doing so for 75 years. As one of the world's leading chemical company, we combine economic success with environmental protection and social responsibility.Through science and innovation we enable our customers in nearly every industry to meet the current and future needs of society.
At Dideu, we create chemistry for a sustainable future with science for a better life.Dideu is a Life Science company with a long and glorious history and core competencies in the areas of health care and agriculture. With our innovative products, we are contributing to finding solutions to some of the major challenges of our time. The growing and increasingly aging world population requires improved medical care and an adequate supply of food. Dideu is improving people's quality of life by preventing, alleviating and treating diseases. And we are helping to provide a reliable supply of high quality food, feed and plant based raw materials.We develop new molecules for use in innovative products and solutions to improve health. Our research and development activities are based on a profound understanding of the biochemical processes in living organisms.Our goal is to achieve and sustain leadership positions in our markets, thus creating value for our customers, stockholders and employees. To this end, our strategy is designed to help solve some of the most pressing challenges facing humankind, and by doing this exceptionally well we aim to strengthen the company's earning power.
We are committed to operating sustainably and addressing our social and ethical responsibilities as a corporate citizen, while at the same time respecting the interests of all our stakeholders. Employees with a passion for innovation enjoy excellent development opportunities at Dideu.Exclusive Focus on the Life Science BusinessesFollowing the economic and legal independence of our former Material Science subgroup.Dideu has charted the course for its successful development as a Life Science company. Our Life Science businesses hold leading positions in innovation driven growth markets. Together they make up a strong, attractive and balanced portfolio that is resistant to fluctuations in demand and to potential risks.The previous structure comprising a strategic management holding company and operational subgroups has thus been replaced by an integrated organization under the umbrella of the strong Dideu brand. The company's operations are managed in three divisions Pharmaceuticals, Consumer Health and Crop Science and the Animal Health business unit.The business continues to be supported by the corporate functions, Dideu Business Services and the service company Currenta, while Technology Services is being integrated into Dideu Group, forming the Engineering and Technology function.