Sterility Testing of Different Sterile Products
-The USP describes the sterility test procedures to be followed for all types of sterile products excluding human biologics, human antibiotics, and veterinary biologics, to which Federal regulations apply.
-Test procedures for the direct transfer to test media are given for the following six types of products:
1. Liquids.
2. Ointments and oils insoluble in isopropyl myristate.
3. Solids.
4. Purified cotton, gauze, surgical dressings, sutures, and related articles.
5. Sterilized devices.
6. Sterile empty or prefilled syringes.
Test procedures for using the MF technique are specified for the following five types of products:
1. Liquids miscible with aqueous vehicles
2. Liquids immiscible with aqueous
vehicles, less than 100 ml per container
3. Filterable solids
4. Ointments and oils soluble in isopropyl myristate
5. Devices
-The USP describes the sterility test procedures to be followed for all types of sterile products excluding human biologics, human antibiotics, and veterinary biologics, to which Federal regulations apply.
-Test procedures for the direct transfer to test media are given for the following six types of products:
1. Liquids.
2. Ointments and oils insoluble in isopropyl myristate.
3. Solids.
4. Purified cotton, gauze, surgical dressings, sutures, and related articles.
5. Sterilized devices.
6. Sterile empty or prefilled syringes.
Test procedures for using the MF technique are specified for the following five types of products:
1. Liquids miscible with aqueous vehicles
2. Liquids immiscible with aqueous
vehicles, less than 100 ml per container
3. Filterable solids
4. Ointments and oils soluble in isopropyl myristate
5. Devices
MCQ NO 651 | pharmaceutics
The drug which is light sensitive
The drug which is light sensitive
Anonymous Quiz
21%
A. Tetracycline
12%
B. Indomethacin
20%
C. Amphotericin B
47%
D. All of the above
MCQ NO 652 | Pharmacology
Which of the following is a neurotrans- mitter in the central nervous system (CNS)
Which of the following is a neurotrans- mitter in the central nervous system (CNS)
Anonymous Quiz
14%
(a) Acetylcholine
8%
(b) Noradrenaline
18%
(c) Dopamine
59%
(e) All of the above
MCQ NO 653 | Pharmacology
Which of the following amino acids is an inhibitory transmitter and increases the membrane permeability to chloride ions, and thus causing inhibitory post synaptic potential (IPSP) in the CNS
Which of the following amino acids is an inhibitory transmitter and increases the membrane permeability to chloride ions, and thus causing inhibitory post synaptic potential (IPSP) in the CNS
Anonymous Quiz
17%
(a) Glycine
25%
(b) Glutamate
12%
(c) Aspartate
46%
D. All of the above
MCQ NO 654 | Pharmacology
Following is a tertiary amine anti-mus- carinic drug mainly used for mydriatic or cycloplegic action
Following is a tertiary amine anti-mus- carinic drug mainly used for mydriatic or cycloplegic action
Anonymous Quiz
20%
(a) Benztropine
31%
(b) Dicyclomine
27%
(c) Pirenzepine
21%
(d) Trpicamide
MCQ NO 655 | pharmaceutical analysis
Reducing sugar in paper chromatography is localized by using...... reagent.
Reducing sugar in paper chromatography is localized by using...... reagent.
Anonymous Quiz
20%
A. Ferric chloride
29%
B. Aniline phthalate
39%
C. Ninhydrine
12%
D. Bromocresol purple
MCQ NO 656 | pharmaceutics
The Crystal form of Sulphacetamide is :
The Crystal form of Sulphacetamide is :
Anonymous Quiz
28%
(a) Rhombohedral
46%
(b) Orthorhombic
19%
(c) Monoclinic
6%
(d) Triclinic
MCQ NO 657 | pharmaceutical engineering
In solid-solid mixing, large scale continuous type of mixer is
In solid-solid mixing, large scale continuous type of mixer is
Anonymous Quiz
34%
(a) Sigma blender
23%
(b) Ribbon blender
28%
(c) Zigzag blender
15%
(d) Twin shell blender
MCQ NO 658 | pharmacognsy
A fixed oil when added to an equal volume of ethanol; clear liquid is obtained; on cooling at O°C and on storage for three hours, the liquid remains clear such fixed oil is identified as :
A fixed oil when added to an equal volume of ethanol; clear liquid is obtained; on cooling at O°C and on storage for three hours, the liquid remains clear such fixed oil is identified as :
Anonymous Quiz
51%
(a) Castor Oil
24%
(b) Soyabean oil
13%
(c) Neem oil
11%
(d) Evening Primrose oil
MCQ NO 659 | Pharmacology
. A typical long bone consists of following parts except
. A typical long bone consists of following parts except
Anonymous Quiz
18%
(a) The diaphysis
35%
(b) The trabeculae
26%
(c) The epiphyses
21%
(d) The periosteum
MCQ NO 660 | organic chemistry
Which of the following rearrangement involves migration of a group from carbon to electron deficient nitrogen
Which of the following rearrangement involves migration of a group from carbon to electron deficient nitrogen
Anonymous Quiz
8%
(a) Wilgerodt rearrangement
29%
(b) Baeyer villiger, rearrangement
34%
(c) Pinacol-pinacolone rearrangement
30%
(d) Beckmann rearrangement
🏆 Top results in the quiz 'IP Topic Wise Test'
• PARENTRAL
🖊 20 questions
📝 456 people took the quiz
🥇 vivek – 15
🥈 Sakshi Awasthi – 14
🥉 Omkar – 14
• PARENTRAL
🖊 20 questions
📝 456 people took the quiz
🥇 vivek – 15
🥈 Sakshi Awasthi – 14
🥉 Omkar – 14
🔴 DEFINITION
Aerosol =
It is a disperse system that functions on the power of a compressed or liquefied gas to expel the contents from the container.
Aerosol =
It is a disperse system that functions on the power of a compressed or liquefied gas to expel the contents from the container.
🔴 DEFINITION
Propellant =
It is the component of the aerosol system which develop pressure within the container and expel the product.
Propellant =
It is the component of the aerosol system which develop pressure within the container and expel the product.
🔴 DEFINITION
Boyle's law =
For a given mass of a gas at constant temperature (T) the pressure (P) is inversely proportional to the volume.
Boyle's law =
For a given mass of a gas at constant temperature (T) the pressure (P) is inversely proportional to the volume.
🔴 DEFINITION
Actuator =
It is the component of the aerosol system which is used to opening the valve and producing required type of discharge.
Actuator =
It is the component of the aerosol system which is used to opening the valve and producing required type of discharge.
🔴DEFINITION
Liquefaction =
It is the process of converting of gases into liquid.
Liquefaction =
It is the process of converting of gases into liquid.
🔴 CLASSIFICATION
Propellants used in Pharmaceutical Aerosols:
🔺1. Chlorofluorocarbons (CFCs)
Trichloromonofluoromethane
Dichlorodifluoromethane
Dichlorotetrafluoroethane
🔺2. Hydrochlorofluorocarbons
(HCFCs)
Difluoroethane
Hydrofluorocarbons (HFCs)
Tetrafluoroethane
Heptafluoropropane
🔺3.Hydrocarbons (HCs)
Butane
Isobutane
Propane
Hydrocarbon Ethers (HEs)
Dimethyl ether
🔺4.Compressed gases (CGs)
Carbon dioxide
Nitrous oxide
Nitrogen
Propellants used in Pharmaceutical Aerosols:
🔺1. Chlorofluorocarbons (CFCs)
Trichloromonofluoromethane
Dichlorodifluoromethane
Dichlorotetrafluoroethane
🔺2. Hydrochlorofluorocarbons
(HCFCs)
Difluoroethane
Hydrofluorocarbons (HFCs)
Tetrafluoroethane
Heptafluoropropane
🔺3.Hydrocarbons (HCs)
Butane
Isobutane
Propane
Hydrocarbon Ethers (HEs)
Dimethyl ether
🔺4.Compressed gases (CGs)
Carbon dioxide
Nitrous oxide
Nitrogen
Aerosols
-The term aerosol is used to denote various systems ranging from those of a colloidal nature to systems consisting of pressurized packages.
-Aerosols have been defined as colloidal systems consisting of very finely subdivided liquid or solid particles dispersed in and surrounded by a gas.
-Originally, the term aerosol referred to liquid or solid particles having a specific size range, but this concept has fallen into disuse.
-The present-day definition refers to those products that depend upon the power of a liquefied or compressed gas to dispense the active ingredient(s) in a finely dispersed spray, foam, or semisolid.
-Topical pharmaceutical aerosols can be formulated as:
•spray
•foam
•semisolid
and can be used to deliver therapeutic agents topically to the skin surface, rectally, and vaginally.
-They consist of a liquid, emulsion, or semisolid concentrate and liquefied gas or compressed gas propellant.
-Many therapeutically active ingredients have been administered or applied to the body by means of the aerosol dosage form.
-In 1978, the use of certain chlorofluorocarbons (CFCs) was curtailed by the FDA, EPA, and CPSC. These restrictions ap- plied to the use of Propellants 11, 12, and 114 (CFCs) for use in all aerosol products.
MODE OF OPERATION
1. Liquefied-Gas Systems
-Liquefied gases have been used widely as propellants for most aerosol products.
-Types of system:
a. TWO-PHASE SYSTEM
-This is the simplest of all aerosol systems. It consists of a solution or a suspension of active ingredients in liquid propellant or a mixture of liquid propellant and solvent.
b. THREE-PHASE SYSTEM
-This system is useful for topical pharmaceutical aerosols in that it allows a greater use of liquid components not miscible with the propellants.
2. Compressed-Gas Aerosols
-Aerosols using compressed gases as the propellant are finding increased use. These propellants, especially nitrogen, carbon dioxide, and nitrous oxide, are acceptable for use with pharmaceuticals.
3. Barrier-Type Systems
-These systems separate the propellant from the product itself. The pressure on the outside of the barrier serves to push the contents from the container.
a. PISTON TYPE
b. PLASTIC-BAG AND BAG-IN-BAG
TYPE
c. CAN-IN-CAN SYSTEMS
-The term aerosol is used to denote various systems ranging from those of a colloidal nature to systems consisting of pressurized packages.
-Aerosols have been defined as colloidal systems consisting of very finely subdivided liquid or solid particles dispersed in and surrounded by a gas.
-Originally, the term aerosol referred to liquid or solid particles having a specific size range, but this concept has fallen into disuse.
-The present-day definition refers to those products that depend upon the power of a liquefied or compressed gas to dispense the active ingredient(s) in a finely dispersed spray, foam, or semisolid.
-Topical pharmaceutical aerosols can be formulated as:
•spray
•foam
•semisolid
and can be used to deliver therapeutic agents topically to the skin surface, rectally, and vaginally.
-They consist of a liquid, emulsion, or semisolid concentrate and liquefied gas or compressed gas propellant.
-Many therapeutically active ingredients have been administered or applied to the body by means of the aerosol dosage form.
-In 1978, the use of certain chlorofluorocarbons (CFCs) was curtailed by the FDA, EPA, and CPSC. These restrictions ap- plied to the use of Propellants 11, 12, and 114 (CFCs) for use in all aerosol products.
MODE OF OPERATION
1. Liquefied-Gas Systems
-Liquefied gases have been used widely as propellants for most aerosol products.
-Types of system:
a. TWO-PHASE SYSTEM
-This is the simplest of all aerosol systems. It consists of a solution or a suspension of active ingredients in liquid propellant or a mixture of liquid propellant and solvent.
b. THREE-PHASE SYSTEM
-This system is useful for topical pharmaceutical aerosols in that it allows a greater use of liquid components not miscible with the propellants.
2. Compressed-Gas Aerosols
-Aerosols using compressed gases as the propellant are finding increased use. These propellants, especially nitrogen, carbon dioxide, and nitrous oxide, are acceptable for use with pharmaceuticals.
3. Barrier-Type Systems
-These systems separate the propellant from the product itself. The pressure on the outside of the barrier serves to push the contents from the container.
a. PISTON TYPE
b. PLASTIC-BAG AND BAG-IN-BAG
TYPE
c. CAN-IN-CAN SYSTEMS