Iron
Dissolve the specified quantity of the substance under examination in water, or prepare a solution as directed in the monograph, and transfer to a Nessler cylinder. Add 2 ml of a 20% w/v solution of iron-free citric acid and 0.1 ml of thioglycollic acid, mix, make alkaline with iron-free ammonia solution, dilute to 50 ml with water and allow standing for 5 minutes. Any color produced is not…
Pharmaceutical Administration and Regulations in Japan
Pharmaceutical Administration and Regulations in JapanFront cover / Contents
CHAPTER 1. ORGANIZATION AND FUNCTION OF THE MINISTRY OF HEALTH, LABOUR AND WELFARE
CHAPTER 2. PHARMACEUTICAL LAWS AND REGULATIONS
CHAPTER 3. DRUG DEVELOPMENT
CHAPTER 4. POST-MARKETING SURVEILLANCE OF DRUGS
CHAPTER 5. SUPPLY AND DISSEMINATION OF DRUG INFORMATION
CHAPTER 6. HEALTH INSURANCE PROGRAMS AND DRUG PRICING IN JAPAN
In…
CHAPTER 1. ORGANIZATION AND FUNCTION OF THE MINISTRY OF HEALTH, LABOUR AND WELFARE
CHAPTER 2. PHARMACEUTICAL LAWS AND REGULATIONS
CHAPTER 3. DRUG DEVELOPMENT
CHAPTER 4. POST-MARKETING SURVEILLANCE OF DRUGS
CHAPTER 5. SUPPLY AND DISSEMINATION OF DRUG INFORMATION
CHAPTER 6. HEALTH INSURANCE PROGRAMS AND DRUG PRICING IN JAPAN
In…
Contents Uniformity (Weight or Volume) of Packaged Dosage Forms
The following tests and specifications apply to oral dosage forms and preparations intended for topical use that are packaged in containers in which the labeled net quantity is not more than 100 g or 300 ml or 1000 units, as the case may be. For higher labeled quantities the test and limits given in the standards of Weights and Measures (Packaged commodities) Rules, 1977 may be followed.
Ointment…
Ointment…
WHO News letter
WHO Newsletter on Risk Management Principles used for WHO Inspections of API facilities - Click here to view Newsletter
Operation and Cleaning of Tablet Inspection Machine
1.0 PRE STARTUP
1.1 Visually check the equipment and area for its cleanliness. Ensure that no remnant of previous product / batch is present.
1.2 Check the temperature and relative humidity of the area and record the details in the respective log books.
1.3 If the environmental conditions are not within the limit, do not start the operation and inform to the maintenance department.
1.4 If the condi…
1.2 Check the temperature and relative humidity of the area and record the details in the respective log books.
1.3 If the environmental conditions are not within the limit, do not start the operation and inform to the maintenance department.
1.4 If the condi…
Thin-Layer Chromatography (TLC Method and Apparatus)
Thin-layer chromatography is a technique in which a solute undergoes distribution between two phases, a stationary phase acting through adsorption and a mobile phase in the form of a liquid. The adsorbent is a relatively thin, uniform layer of dry finely powdered material applied to a glass, plastic or metal sheet or plate. Glass plates are most commonly used. Separation may also be achieved on t…
Procedure for Operation and Cleaning of Rapid Mix Granulator (RMG)
PRE-STARTUP
1. Check the cleanliness of the room.
2. Check the material lying in the room is of the same batch to proceed.
3. Remove the clean status label of the equipment and tear off them after confirming the details.
4. Put the equipment label on the machine.
AT THE TIME OF BATCH CHANGEOVER OF THE SAME PRODUCT 1. Check and ensure the cleanliness of the equipment/ area.
2. Remove the clean equipm…
2. Check the material lying in the room is of the same batch to proceed.
3. Remove the clean status label of the equipment and tear off them after confirming the details.
4. Put the equipment label on the machine.
AT THE TIME OF BATCH CHANGEOVER OF THE SAME PRODUCT 1. Check and ensure the cleanliness of the equipment/ area.
2. Remove the clean equipm…
Drug Information Update- FDA Approves Rituxan to Treat Two Rare Disorders
The U.S. Food and Drug Administration today approved Rituxan (rituximab), in combination with glucocorticoids (steroids), to treat patients with Wegener’s granulomatosis (WG) and microscopic polyangiitis (MPA), two rare disorders that cause blood vessel inflammation (vasculitis).
Vasculitis in patients with WG and MPA can lead to tissue damage. WG mostly affects the respiratory tract (sinuses, no…
Vasculitis in patients with WG and MPA can lead to tissue damage. WG mostly affects the respiratory tract (sinuses, no…
Testing Procedure (Method of Analysis) for Lactates, Lead Compounds and Magnesium Salts
Lactates
To 5 ml of a solution of the substance under examination containing about 5 mg of lactic acid or to 5 ml of the prescribed solution add 1 ml of bromine water and 0.5 ml of 1M sulphuric acid. Heat on a water-bath, stirring occasionally with a glass rod until the color is discharged. Add 4 g of ammonium sulfate, mix and add dropwise, without mixing, 0.2 ml of a 10 percent w/v solution of …
Procedure for Operation and Cleaning of Metal Detector
1.0 PRE STARTUP
1.1 Ensure that no remains of previous product/ batch are present.
1.2 Visually check the equipment and area for its cleanliness.
1.3 Ensure “CLEANED” label on the equipment.
1.4 Ensure specified temperature and relative humidity of the area.
1.5 Ensure that the equipment is getting single phase alternating current supply.
1.6 Ensure that the metal detector is in working condition.
1.7…
1.2 Visually check the equipment and area for its cleanliness.
1.3 Ensure “CLEANED” label on the equipment.
1.4 Ensure specified temperature and relative humidity of the area.
1.5 Ensure that the equipment is getting single phase alternating current supply.
1.6 Ensure that the metal detector is in working condition.
1.7…
Determination of Nitrogen
Use method E for substances containing 2 mg or less of nitrogen.
Method A
Weigh accurately the quantity of the substance under examination specified in the individual monograph or a quantity equivalent to about 35 mg of nitrogen into a 200-ml long-necked flask and add 3 g of anhydrous sodium sulfate, 0.3 g of nitrogen-free mercuric oxide and 20 ml of nitrogen free sulphuric acid, unless otherwise…
Operation and Cleaning of Mechanical Sifter
PRE-STARTUP (AT THE BEGINNING OF SHIFT)
1. Check the cleanliness of the room.
2. Check the material lying in the room is of the same batch to proceed.
3. Remove the clean status label of the equipment and tear off them after confirming the details.
4. Put the equipment label on the machine.
AT THE TIME OF BATCH CHANGEOVER OF THE SAME PRODUCT 1. Check and ensure the cleanliness of the equipment/ are…
2. Check the material lying in the room is of the same batch to proceed.
3. Remove the clean status label of the equipment and tear off them after confirming the details.
4. Put the equipment label on the machine.
AT THE TIME OF BATCH CHANGEOVER OF THE SAME PRODUCT 1. Check and ensure the cleanliness of the equipment/ are…
Preparation and Standardization of Volumeteric Solutions
Following are the generally used volumetric solutions used in the analysis of pharmaceutical ingredientsPreparation and Standardization of 0.05 M Iodine
Preparation and Standardization of 0.1 M Lead Nitrate
Preparation and Standardization of 0.1 M Lithium Methoxide
Preparation and Standardization of 0.05 M Magnesium Sulphate
Preparation and Standardization of 0.02 M Mercuric Nitrate
Preparation and S…
Preparation and Standardization of 0.1 M Lead Nitrate
Preparation and Standardization of 0.1 M Lithium Methoxide
Preparation and Standardization of 0.05 M Magnesium Sulphate
Preparation and Standardization of 0.02 M Mercuric Nitrate
Preparation and S…
Sterility Validation (Membrane Filtration Method) in Pharmaceuticals
1.0 INTRODUCTION
When any test for sterility is initially carried out for any product, it is necessary to validate the test method used, by the recovery of a few numbers of microorganisms in the presence of the product.
2.0 OBJECTIVE The Objective of this validation is to establish documented evidence that the test for sterility by membrane filtration method will produce the consistent results w…
2.0 OBJECTIVE The Objective of this validation is to establish documented evidence that the test for sterility by membrane filtration method will produce the consistent results w…