Commercial Manufacturing Extemporaneous Processing

Question 1

The process of INCREASING the batch size
Applying SAME process to different output volume

Answer 1

Scale up

Question 2

Processes exist for which ______ simply means enlarging the output by INCREASING the speed

Answer 2

Scale up

Question 3

In moving from R&D to production scale, it is sometimes essential to have

Answer 3

Intermediate batch scale

Question 4

Manufacturing of drug product by a procedure fully representative of and simulating that used for FULL MANUFACTURING SCALE

Answer 4

Pilot scale

Question 5

This scale also makes possible the production of enough product for

Answer 5

Clinical testing
Samples for marketing

Question 6

One way to eliminate potential scale up problems is to develop

Answer 6

Formulations that are very robust

Question 7

ISOLATION of a single chemical constituent of chemically related substance

Answer 7

Separation

Question 8

Separation process

Uses a SINGLE mechanical manipulation

Answer 8

Simple process

Question 9

Used to separate two IMMISCIBLE liquids

Answer 9

Separatory funnel

Ethyl acetate+Chloroform
Peppermint+Water

Question 10

Processes under simple process

Answer 10

Separatory funnel
Distillation
Garbling
Centrifugation

Question 11

Used to separate two MISCIBLE liquids

Answer 11

Distillation

Question 12

Used to separate two SOLIDS

Answer 12

Garbling

Question 13

Used to separate SOLID from LIQUID

Answer 13

Centrifugation, filtration, expression

Question 14

Separation process

It requires the formation of a SECOND PHASE + mechanical manipulation

Answer 14

Complex process

ASA from salicylic acid - recrystallize ASA

Question 15

Separation process where an OPTICALLY TRANSPARENT liquid is obtained that passes through a POROUS substance

Answer 15

Filtration

Question 16

In filtration the LIQUID OBTAINED is called

Answer 16

Filtrate

Question 17

What is easier to filter larger or smaller particles

Answer 17

Larger particles

Question 18

Smaller particles:

Answer 18

HINDERS FILTRATE
Have the tendency to occlude the pores
Build up on the filter form a non-porous, densely packed bed

Question 19

Has channels that impart POROSITY

Answer 19

Filtering media

Question 20

Full of TINY HOLES that water or air can get through

Answer 20

Porosity

Question 21

Ability of the filter medium to ELIMINATE SOLID material from the liquid

Answer 21

Retention

Question 22

SPEED at which the purified liquid or filtrate is recovered

Answer 22

Filtration rate

Question 23

Speed of the FLOW of the liquid through the filter bed
Retarded by the

Answer 23

Flow rate

Viscosity of the liquid

Question 24

Types of filtering media

Answer 24

Filter paper
Membrane filters
Cotton filters
Glass wool filters
Sintered glass filters

Question 25

Types of filtering media Folded or fluted

Answer 25

Filter paper

Question 26

Types of filtering media Similar to cloth Pure or derived cellulose products with UNIFORM MICROPORE STRUCTURE (10nm to 10um) Used in

Answer 26

Membrane filters Chemical, microbiological, bacterial analyses

Question 27

Types of filtering media Absorbent Loosely inserted in the neck of the funnel Disadvantage?

Answer 27

Cotton filters Refiltration

Question 28

Types of filtering media Resistant to chemical action= used for highly reactive chemicals

Answer 28

Glass wool filters

Question 29

Types of filtering media Flat or convex plate with JENA POWDERED glass molded together Vacuum attachment Used to filter?

Answer 29

Sintered glass filters Parenteral solutions

Question 30

What to do for filtration of volatile liquid to avoid loss or explosion

Answer 30

Cover the funnel and the receiving vessel

Question 31

They increase EFFICIENCY of the filtration process Must be

Answer 31

Adsorbents Soluble and inert

Question 32

It is not the palpable kind

Answer 32

Purified talc

Question 33

INCAPABLE of being felt by touch; so FINELY divided that no grains or grit can be felt

Answer 33

Impalpable

Question 34

Used for GENERAL filtration process Inert Adsorbs liquid

Answer 34

Kieselghur or pure silica

Question 35

Fuller's earth or kaolin in HYDRATED form Used to filter FIXED OILS but should not be used for liquid with coloring matter or alkaloidal principles

Answer 35

Siliceous earth or clay

Question 36

Adsorbs color, odor, alkaloids, and glycosides

Answer 36

Charcoal

Question 37

READILY react with acids and possess a FINITE solubility in water with a production of an alkaline aqueous solution which can PRECIPITATE alkaloids NOT for?

Answer 37

Chalk, Magnesium carbonate General filtration processes

Question 38

AIDS in the filtration processes Can use PUMP-ACTING process by water pressure where no leaks should be present in the connections Example?

Answer 38

Vacuum filtration Buchner filter (common) Gooch crucible perforated Flask

Question 39

The process by which FINELY divided solids and colloidal materials are separated from liquids WITHOUT the use of filters Employed when? Tend to plug a?

Answer 39

Clarification FINELY subdivided, amorphous or colloidal in nature Filtration medium rapidly

Question 40

Method of clarification SIMPLEST method- least amount of labor and expense The sediment formed is a _____ which separates due to GRAVITY from a liquid Example?

Answer 40

Gravitational method Sludge Fixed oils and vegetable oils

Question 41

Method of clarification It is added, shaken and removed by filtration Acts to _____ by physical adsorption Example?

Answer 41

Clarifying agent Reduce turbidity Paper, Talc albumin, Gelatin and polyamines

Question 42

A process of DEPRIVING solutions of color by use of an adsorptive medium Example?

Answer 42

Decolorization Animal charcoal/bone black, wood charcoal, activated charcoal, bentonite, kaolin, fuller's earth

Question 43

Difference of adsorption to absorption

Answer 43

Adsorption: particles stick to the surface Absorption: enters the cell

Question 44

The SIMPLEST method for the separation of a solid from it's soluble impurities Involves WASHING and subsequent AGITATION of the solid Repeated to attain the degree of Conveniently done with a _____ that is not filled to capacity _____ used as a guide to STEADY the hand of the operator

Answer 44

Decantation Desired purity Lipped vessel Stirring rod

Question 45

STRAINING It separates the solid from the liquid by pouring the mixture on a CLOTH or POROUS material that will permit the fluid to pass through but will retain the solid It is filtration using _____ in the straining medium/cloth which is colorless and washed before use

Answer 45

Colation Larger pores

Question 46

FORCIBLY separating liquids from solids

Answer 46

Expression

Question 47

Methods of expression BEST method that uses a cloth

Answer 47

Spiral twist test

Question 48

Method of expression For LARGE SCALE pressing of oily seeds, fatty substances _____ must be taken to apply the force gradually and not to use it on _____ What material does it use

Answer 48

Roller press Care, corrosive materials Rubber

Question 49

Method of expression EXPENSIVE but most economical in terms of increased power with least labor The principle is based on the fact that pressure exerted upon an enclosed liquid is transmitted _____ in all directions

Answer 49

Hydrostatic or hydraulic press Equally To extract active constituents

Question 50

Steps of precipitation and recrystallization Evaporate solvent= cool= formation of crystals

Answer 50

Supersaturation

Question 51

Steps of precipitation and recrystallization Thought to consist of 10 to a few hundred of molecules having the SPATIAL ARRANGEMENT of the crystals that will be grown ultimately from them

Answer 51

Formation of nuclei

Question 52

Steps of precipitation and recrystallization Suspension= formation of HARD CAKE or also known as?

Answer 52

Growth of crystals Oswald ripening

Question 53

Depending on the conditions of crystallization, it is possible to control or modify the nature of crystals obtained Careful TEMPERATURE CONTROL and SEEDING with desired crystal form is necessary

Answer 53

Existence of polymorphs

Question 54

Depending on the conditions of crystallization, it is possible to control or modify the nature of crystals obtained Depends highly on IMPURITIES in the solution, pH, rate of stirring, rate of cooling and the solvent

Answer 54

The habit or shape of the crystal form