Source

EUROPE HALAL CERTIFICATION BODIES
ENHANCEMENT PROGRAMME
KNOWING HALAL INGREDIENTS
Mr. Fakaruddin Masod
Halal Hub Division
Department of Islamic Development Malaysia (JAKIM)
MALAYSIA
Cross contamination
Ingredients
Synchronise the
Information
Science &
Technology
Issue &
challenge
Halal Analysis
Enforcement
Halal Assurance
Management System
Halal Food Production Chain
Critical ingredient
• FOOD & BEVERAGES
• COSMETIC &
PERSONAL CARE
• PHARMACEUTICAL
5
IDENTIFY SOURCE
ANIMAL
PLANT
CHEMICAL
STATUS OF INGREDIENT
STATUS OF INGREDIENT
Slaughtered according to
syariah
Not slaughtered according to
syariah
HALAL ISSUE ON INGREDIENT
Gelatine
Stearic Acid
Glycerol
Ingredient
Alcohol
Enzyme
Critical ingredient
PROTEIN & AMINO
ACID
Eg : Gelatine , lecithin
ENZYME
Eg : Meat tenderizer, yoghurt
FATS & OIL
Eg: Cooking oil, Emulsifier (glycerine)
ALCOHOL
Eg : solvent for flavour
FATS AND OIL
Critical Ingredient
ANIMAL FAT
FATS & OIL

Stabilizer

Improve texture

Emulsifier

Flavour carrier
FUNCTION
Emulsifier -glycerine, mono and diglyceride
Antioxidants
Vitamins -vitamin A, Vitamin D, Panthenol (vitamin BComplex),
Polysorbate, monosorbate
Isopropyl myristate
Lard
Fatty Acid
Linoleic acid, myristic acid, oleic acid, stearic acid, palmitic
acid etc
Lipid - lipoid
VEGETABLE FAT
GLYCEROL / GLYCERIN
Production
• Triglyceride
• Propylene (chemical reaction)
Source
• Animal fat (porcine, ovine, bovine)- glycerin
• Vegetable fat - glycerol
• Synthetic
Application
• Solvent, preservative
FATS AND OIL: SOURCES
FATS AND OIL: SOURCES
FATS AND OIL: SOURCES
PROTEIN & AMINO
ACID
WHAT IS PROTEIN & AMINO ACIDS?
tissue
Source-
protein
Amino
acid
WHY PROTEINS & AMINO ACID USED AS INGREDIENTS?
• Nutrient supplement for human
• Processing aids
• Functional ingredient to impact specific
characteristics
PROTEIN AND AMINO ACID: FOOD INGREDIENT
Yogurt,
chocolate
product, ice
cream
L-CYSTEINE
•
•
•
•
Amino acid derived from animal or human hair (and feathers)
Alternative source: chemically synthesized, plant source
Application: bakery products
Function: dough improver, dough conditioner, dough
strengthener
FOOD INGREDIENT: GELATIN
• Partial hydrolysis of collagen derived from animal skin, white
connective tissue, and bones.
• Translucent, colorless, brittle (when dry) and flavorless solid
substance
• A special and unique hydrocolloid, serving multiple functions
with a wide range of applications.
• Main sources- pigskin, cattle bones and cattle hide
• Application:
▫
Bakery product, dairy product, dessert, jelly, marshmallow,
confectionary
LECITHIN
• It is a mixture of various phospholipids, and the composition
depends on the origin of the lecithin.
• Obtained from animal and vegetable through physical procedures
• A major source of lecithin is soybean oil
• Function: emulsifier, lubricant, food coating, surfactant,
stabilizer, antioxidant
• Application: Confectionary, dietary supplement, bakery product
RENNET: HALAL ISSUES
• During the production of cheese, rennet is commonly used as the coagulating
agent.
• In rennet, there is an enzyme called rennin that curdles the milk.
• The sources of rennet are from young mammals stomach.
• Mammals consist of cows, goats and also pigs.
• Rennet is extracted from the stomach by adding acid, which separates the
different enzymes. Manufacturers make 1 kilogram of cheese that usually
contains around 0.0003 grams of rennet.
Rennet (4 majors type)
An enzyme used to coagulate milk for cheese production.
calf
rennet
5% of
domestic
Europea
ncheese
today
microbi
al
rennet
fermentation-produced
chymosin or rennin
attributed 90% of cheese
production in the U.S
Produce through
fermentation process
using genetically
modified microorganisms
bioengineered to produce
bovine chymosin (calf
genetic material).
vegetable
coagulants
Whey protein?
• History of whey started since 3000 years BC,
when Bedoiuns (desert-dweller, nomadic
groups) carried milk in bags made out of
animals stomach.
• The heat in the desert caused acidification and
coagulation in milk, resulting in an acid liquid
(whey) on top of milk curd sediment (cheese).
• Whey is the liquid remaining after the
production of cheese or the removal of fat and
casein (80% of the protein from milk)
• Worldwide production of whey is estimated to
be over 100 billions kilograms per year
Constituents of whey
Whey is a nutritious
liquid (water soluble
protein) containing
mainly β-lactoglobulin ,
α-lactalbumin
Bovine serum albumin &
Immunoglobins) and
lactose
•minor constituentsvitamins and minerals
and also enzymes,
hormones and growth
factors.
Infant formula
ENZYMES
Enzymes are biocatalysts which accelerate
the rate of chemical reactions
All proteins
Present in all living cells
Exhibit a high specificity
3,000 different enzymes have been isolated
and classified
Enzymes in Man
The enzymes inside the mouth are contained inside of the saliva.
The saliva is mostly water -- about 97 to 99.5 percent -- the rest is
made up of enzymes, mucus, antibodies and electrolytes.
Salivary amylase, lingual lipase and lysozomes are the salivary
enzymes located inside the mouth.
Enzyme in Foods
Source of Industrial Enzymes
Plant
Animal
Are these
Halal ?
Fungi
Microbes
Approved by the United States FDA- Pancreatic
enzymes
Creon® capsules
Pancreaze® capsules
Pertzye® capsules
Ultresa® capsules
Viokace® capsules
Zenpep® capsules
All are derived from pigs
• Microorganisms-greater Industrial
Importance
More stable
Can be obtained in bulk at a
lower cost
High growth rate and larger
proportion of enzymes in
relation to their body mass
compared to plants or
animals
Shorter time to harvest
Easily cultivated and not
affected by climate
Typical enzymes used in industrial processes
CLASS
INDUSTRIAL ENZYMES
1. Oxidoreductases
Peroxidases
Catalases
Glucose oxidases
Laccases
2. Transferases
Fructosyl-transferases
Glucosyl-transferases
3. Hydrolases
Amylases
Cellulases
Lipase
Pectinases
Proteases
Pullulanases
4. Lyases
Pectate lyases
Alpha-acetolactate
Decarboxylases
5. Isomerases
Glucose isomerases
6. Ligases
Currently not used
Microbial Enzymes
Screening and selection of microbial
•
strains
Production and purification of Enzymes
Enzymes and immobilization
Recombinant DNA technology
a. Directly- Meat tenderizer, yogurt , beverage
b. Indirectly- Production of emulsifier (ingredient), Structured
lipid,
Application
Enzymes used
Uses
Food Processing
Amylases catalyze the release of
simple sugars from starch
Amylases from fungi
Production of sugars from starch, such as in making highfructose corn syrup. In baking, catalyze breakdown of
starch in the flour to sugar.
Proteases
Biscuit manufacturers use them to lower the protein level
of flour
Baby foods
Trypsin
To predigest baby foods
Fruit juices
Cellulases, Pectinases
Clarify fruit juices
Dairy industry
Rennin, Microbially produced
enzyme
Manufacture of cheese, used to hydrolyze protein
Lipases
Production of Roquefort cheese to enhance the ripening
of the blue-mould cheese
Lactases
Breakdown lactose to glucose and galactose
Meat tenderizers
Papain
To soften meat for cooking
Starch industry
Amylases, amyloglucosideases
and glucoamylases
Converts starch into glucose and various syrups
Glucose isomerase
Convert glucose into fructose in production of high
fructose syrups. These syrups have enhanced
sweetening properties and lower calorific values than
sucrose for the same level of sweetness
Enzyme Name
GE Organism
Use (examples)
α-acetolactate decarboxylase
bacteria
Removes bitter substances
from beer
α-amylase
bacteria
Converts starch to simple
sugar
Catalase
fungi
Reduces food deterioration
Chymosin
bacteria or fungi
Clots casein to make cheese
β-glucanase
bacteria
Improves beer filtration
Glucose isomerase
bacteria
Converts glucose to fructose
Glucose oxidase
fungi
Reduces food deterioration
Lipase
fungi
Oil and fat modification
Maltogenic amylase
bacteria
Slows staling of breads
Pectinesterase
fungi
Improves fruit juice clarity
Protease
bacteria
Improves bread dough
structure
Xylanase (hemicellulase)
bacteria or fungi
Enhances rising of bread
dough
•
•
•
•
The Microbe/ Starter culture ?
Growth Media for the Microbe ?
Others ingredients involves-emulsifier?
The process according to laws of Islam?
Growth Media
Fish blood is a component of growth media
The potential production of fish blood is about 12,000 metric
tons in 2006. Salmon blood, for example, contains easily
digested proteins and a high concentration of polyunsaturated
Omega-3 fatty acids
Is it Halal ?
HALAL ISSUE ON SURIMI
Surimi based product:
Fishball, fishcake, filament crab stick
HALAL ISSUE:
SOURCE OF TRANSGLUTAMINASE
Function of transglutaminase:
- An enzyme that catalyzes the formation of a covalent bond between a free amine
group and the gamma carboxamide group of protein or peptide (EC 2.3.2.1.3)
- to improve the gelling properties of surimi is prohibited for Muslim consumers
• Surimi from various species has been used in different countries for
producing surimi based products such as fish cakes, fish balls, fish
burgers, fish sausages,fish noodles, imitation crab sticks and imitation
shrimp
• A textural characteristic expressed in terms of gel strength is the primary
determinant for surimi quality and price.
• The most commonly used inhibitors are bovine plasma protein
• One of the methods which can be used for detection is Enzyme-linked
Immunosorbent assay (ELISA
)
Source of transglutaminase?
MICROBE
BLOOD
PLASMA
√
Critical Ingredient
ALCOHOL
ALCOHOLIC
BEVERAGE
INDUSTRIAL
ALCOHOL
Industrial application
GRAIN ALCOHOL
Source:
sugarcane molasses, corn,
sugarbeet
SYNTHETIC ALCOHOL
Source: petrochemical
(ethylene)
National Fatwa ‘Alcohol In Food, Drinks, Perfume And Drug’ by the
Special Dialogue of Fatwa Committee of the National Council for Islamic Religious Affairs Malaysia
(14-16 July 2011)
COLLAGEN
 Sources:
• mostly found in fibrous tissues such as tendon, ligament and skin
(bovine & porcine)
• scales and skin (fish)
 Function:
• decrease wrinkles and other signs of aging
• healing of burns
 Product: Eye mask & skin care
GELATINE
A complex combination of proteins obtained from
hydrolysis of collagen
Source:
• Mammalian – pig skin & cattle hide
• Aquatic sources – fish skins, scales & bones
• Poultry sources - skin and bone material
Function:
• Film Forming
• Viscosity controlling
Product : topical creams, acting as a product
texture conditioner, and moisturizer
HALAL ISSUES OF GELATIN
 More than 95% gelatin in the market today is from non-
halal or doubtful sources
 About 70% is used as edible gelatin – Muslim consumer is
vulnerable to the consumption
VITAMIN
• The most widely used vitamins in cosmetics are vitamin
A, C, E and provitamin B5.
• Products: Facial cream, Anti aging, Whitening
skincare, Brightening serum, Facial toner,
Facial wash, Moisturizer, Lotion & Anti blemish
skincare
Active Form
Solubility
Source
Function
Vitamin A
Retinoic acid, retinol,
retinal,
retinyl palmitate, retinyl
acetate
Fat-soluble
- fish liver oil
- Plan sources
- Synthetics
• Improves collagen
density
• skin elasticity, tone,
texture, lines &
wrinkles
• smoothes skin
surface
• skin normalizer
• rejuvenating agent
Vitamin E
-tocopherol, tocopherol
acetate, -tocopherol
sorbate
(note: dl-tocopherols =
synthetic, d-tocopherols =
natural)
Fat-soluble
- Plant sources
(vegetable oils from
soya beans, rapeseed
and sunflower)
- synthetic
• protects from oxidant
damages
• moisturizing
• anti-inflammatory
• healing
• anti-aging effects
Vitamin C
L-ascorbic acid, ascorbyl
palmitate, magnesium
ascorbyl phosphate
Water-soluble
(ascorbyl palmitate is
fat-soluble)
- Plant sources
-Synthetics
• skin-lightening
• anti-inflammatory
agent
• antioxidant
• regenerate vitamin E
• stimulate collagen
synthesis
• reduce dark
pigmentation of the
skin (e.g. age spots)
• anti-aging
Provitamin
B5
D-panthenol, ethyl
panthenol
Water-soluble
- animal
- plant sources
- Synthetics
• Attracts water to hair
& skin
• moisturizing
• regenerating &
softening effects
HYALURONAN
 It is also called hyaluronic acid or hyaluronate or HA
 Source: connective tissue of animals
 Function: used as humectant, antioxidant, stimulating agent for
collagen synthesis and cell proliferation and cytotaxis, and
believed to be a key factor in fighting aging
 Product: Skin care & lipstick
UREA
 Source:
• Urine of mammals
• Chemically synthesis
 Function:
• minimizes the change in the acid/base balance of a product
when other ingredients are added to that product
• increases the water content of the top layers of the skin
 Product: Skin care, hair care, face cream, body cream and lotion
ALLANTOIN
 It is also called Urea, 5-ureidohydanton or glyoxyldiureide
 Sources:
• Comfrey plant
• Urine of cows and most mammals
• Chemically synthesized
 Function: Skin conditioning, skin protecting, soothing.
 Product: anti-aging, sunscreen SPF 15 and above, shampoo, facial
cleanser
STEM CELLS
Defined as:
 unspecialized cells
 multiply themselves
 differentiate into more mature cells
Sources:
 Plant stem cell
 Algae derived stem cell
 Human stem cell : embryo, tissues of the fetus,
the umbilical cord, placenta and in several adult
organs
Function:
• Anti ageing / decreases wrinkles
• Reconstructive surgery
• Boost production of human stem cell (epidermal layer of
the skin)
• Protect and rejuvenate skin stem cells by combating
environmental and UV stress
 Product: Face serum, Anti aging night care, Sunblock cream,
Moisturizer & Face lifting serum
ALCOHOL
 According to USFDA (2000), cosmetic labeling, use the term
‘alcohol,’ to refer ethyl alcohol
• Use denatured alcohol
 Source:
• fermentation of carbohydrates
• reductive cleavage of natural fats and oils
• chemical synthesis from petrochemical source
 Function:
• as a vehicle to deliver ingredients to the skin’s surface
• easy dissolution of the perfume oils into a clear, transparent,
homogeneous solution aesthetic property-evaporating quickly,
cooling the skin and strong lift of the fragrance after apply to skin
 Product: Facial toner, makeup remover, sanitizer &
perfume
The use of industrial alcohol in pharmaceutical, cosmetic
and fragrances product are permissible (National Islamic
Fatwa Council of Malaysia,1984)
However there are some of the cosmetic products use the
alcohol from intoxicating beverage as the ingredient
▫ Eg. Alcohol from sake, pitera (yeast) from sake brewery
BOTOX (Botulinum Toxin)
 Sources: bacteria Clostridium botulinum
 Function: prevent development of wrinkles by paralyzing facial
muscles
 Product: Facial injection
PLACENTA
 Sources: mammals placenta
 Function:
• source of protein and hormones, predominantly estrogen and
progesterone
 Product: bust creams, eye creams, face creams,
masques, cellulite treatments, hand creams,
soaps & hair products
EXTRACT OF SEAWEED
 It is also refer to alginate or carrageenan
 Sources: Marine algae
 Function: thickening agents, water-binding agents, and
antioxidants, potential skin irritants
 Product: Toothpaste, body cream and soap & hair care
FAT AND ITS DERIVATIVE
 Common fat and its derivatives used in the cosmetic are
lard, tallow, glycerin, and fatty acid
 Source:
• Lard (fat from hog abdomens)
• Tallow (rendered beef fat)
• Glycerin (derived from animal or vegetable fat)
• Fatty acid (derived from animal or vegetable fat)
 Function: Denaturant, Humectants, Perfuming & Solvent
 Product:Perfumes, antiaging skin products, moisturizer, face
powder, hair conditioning, lipstick, nail polish, coloring
products, Sunscreen & deodorant
1. API
2. Primary Excipients
3. Secondary Excipients
 Diluents (Fillers)
•
•
•
•
•
•
•
 Binders (Adhesives)
 Disintegrants
 Lubricants
 Antiadhesives
 Glidents
Solvents/co-solvents
Coloring Agents
Flavouring Agents
Sweeteners
Coating Agents
Plasticizers
Wetting Agents
4. Miscellaneous
Excipients









Buffers
Preservatives
Anti-oxidants
Suspending/Surfactant
Agents
Anti-Foaming Agents
Thickening Agents
Humectants
Adsorbents
Waxes
1.
Gelatin
5.
Enzyme
4.
Alcohol
Common
Non-Halal
Excipients
2.
Stearic
Acid
3.
Glycerol
Gelatin
Production:
Product obtained from
acid, alkaline or enzymatic
hydrolysis of collagen.
Characteristics:
Skin, bone and connective
tissue of animal, including
fish and poultry.
Mostly originated from
porcine.
Used in food (jelly),
pharmaceutical
(capsule), cosmetic
(shampoo) and
photography .
Types:
Type A: Acid-treated
precursor
Type B: Alkali-treated
precursor
Source:
• Stable when dry
• Degraded when moist
• Digested and absorbed
• Tasteless and odorless
72
2. Stearic Acid
Production
• Boiling of fat and oil with soda lye  decompose using
HCl  isolation  stearic acid
Source
• Animal fat – ovine, bovine, porcine (up to 30% yield)
• Vegetable oil – olive oil (up to 5% yield)
Pharmaceutical application
• Magnesium stearate (glidant/lubricant)
• Calcium stearate (anti-adherent)
73
Glycerol
Production:
Source:
1. Triglyceride in fat 
hydrolysis  glycerol
1. Animal fat (eg: porcine,
bovine, ovine)
2. Propylene  cascade of
reaction glycerol
2. Vegetable oil (palm, olive oil)
3. Synthetic chemical
Pharmaceutical Application:
1. Lubricant
2. Humectant
3. Laxative
Alcohol
ACCORDING TO NATIONAL FATWA COUNCIL:
1. Every liquor is alcohol but not all alcohol is liquor. Alcohol obtain
from liquor production process is Haram and Najs.
2. Alcohol obtained not from liquor production is not Najs, but
Haram to be consumed in its original form as it is a poison.
3. Drinks produced not with the intention to make liquor and have
alcohol level below 1% v/v is Mubah (harus) to be consumed.
4. Medicine and fragrance containing alcohol as solvent is Mubah and
not Najs if the alcohol is not obtained from the liquor production.
75
Enzyme
Enzyme responsible for many biochemical reaction in
microorganism, plant, animal and human.
Commercially, it can be obtained from animal tissue, plant
or microbes. Though most of the enzyme obtained from
microbial fermentation, pig enzyme is still widely used.
Pancreas: amylase, chymotrypsin, lipase, pancrelipase
Gastric mucosa: pepsin
Small intestine: trypsin
Liver: uricase
Trypsin is the most commonly used in pharmaceutical industry
especially in tissue and cell culture. It decomposes protein as
food source for microbes or help in certain protein production.
76
Pig Organs And Their Products
LIVER
• Uricase
• Arachidonic acid
STOMACH
• Pepsin
• Castle’s intrinsic factor
77
Pig Organs And Their Products
FAT
• Glycerol
• Stearic acid
SKIN
• Gelatin
78
Pig Organs And Their Products
BONE
• Gelatin
• Chondroitin sulphate (cartilage)
PANCREASE
• Amylase
• Insulin
• Lipase
• Chymotrypsin
79
Pig Organs And Their Products
SMALL INTESTINE
• Trypsin
80
HOW TO IDENTIFY THE TYPE OF SOURCES?
1. Via primary sources: research studies
published in medical journal.
2. Via secondary sources: journal/magazine
article which interpret or reviews previous
findings.
3. Via tertiary sources: textbooks,
monographs, handbooks, published
symposia.
81
82
Example: British Pharmacopeia
83
Animal Adjectives
• ant/formicid, bee/apian, bird/avian, crow/corvine,
songbird/oniscine, cod/gadoid, carp/cyprine, fish/piscine,
gull/laridine, wasp/vespine, butterfly/papilionaceous,
worm/vermian, spider/arachnidan, snake/anguine,
turtle/testudinian, cat/feline, rabbit/cunicular,
hare/leporine, dog/canine, deer/cervine, mouse/murine,
reindeer/rangiferine, fox/vulpine, wolf/lupine, goat/caprine,
sheep/ovine, swan/cygnean, duck/anatine,
starling/sturnine, goose/anserine, mongoose/herpestine,
grouse/tetraonine, ostrich/struthionine, horse/equine,
chicken/gallinaceous, cattle/bovine, pig/porcine,
agouti/dasyproctine, whale/cetacean, kangaroo/macropine,
ape/simian, frog/batrachian, bear/ursine, man/human or
hominid (gender specific: man/masculine, woman/feminine)
• Latin influence on English that means "like this animal"
84
Lupine - Wolf
Vulpine - Red Fox
Alopine - Arctic Fox
Musteline - Weasel
Martine - Sable
Phocine - Seal
Myrmecophagine - Anteater
Bubaline - Water Buffalo
Caprine - Ibex
Cervine - Deer
Lapine - Hare
Bosine - Yak
Butine - Hawk
Acrine - Frog
Meline - Badger
Macropodine - Kangaroo
Actinine - Sandpiper
Varanine - Monitor Lizard
Ursine - Grizzly Bear
Orcine - Killer Whale
Delphine - Dolphin
Dasypine - Armadillo
Crotaline – Rattlesnake
Colubine - Racer Snake
Aegypine - Vulture
Terrapine - Turtle
Geochine - Tortise
Sylvine - Cottontail
Spermophine - Ground Squirrel
Petaurine - Flying Squirrel
Sciurine - Tree Squirrel
Pongine - Orangutan
Sarcophine - Tasmanian Devil
Procyonine - Raccoon
Larine - Seagull
Viverrine - Civet
Herpestine - Meerkat
Proboscine - Elephant
Castorine - Beaver
Cricetine - Hamster
Rhombomine - Gerbil
Glirine - Dormouse
Hystricine - Porcupine
Cavine - Guinea Pig
Columbine - Dove
Kobine - Waterbuck
Isodine - Bandicoot
Helodine - Gila Monster
Alaudine (Skylark-like - Obscure)
Anserine (Goose-like)
Aquiline (Eagle-like)
Asinine (Ass-like)
Cancrine (Crab-like)
Colubrine (Snake-like)
Corvine (Crow-like)
Elapine (Poisonous Snake-like)
Elaphine (Stag-like)
Falconine (Falcon Or Hawk-like)
Gruine (Crane-like)
Hircine (Goat-like)
Leonine (Lion-like)
Leporine (Rabbit-like)
Lyncine (Wildcat-like)
Murine (Rodent-like)
Oscine (Songbird-like)
Pavonine (Peacock)
Picine (Woodpecker-like)
Psittacine (Parrot-like)
Ranine (Frog Or Toad-like)
Rusine (Rusa Deer-like)
Serpentine (Snake-like)
Soricine (Shrew-like)
Strigine (Owl-like)
Tigrine (Tiger-like)
Vespertilionine (Bat-like)
Volucrine (Bird-like)
Vulpine (Fox-like)
Zebrine (Zebra-like)
85
Focus: OTC
Tab, Cap &
Liquid
1. Tablet
Most
Common OTC
Oral Dosage
Form
3. Liquid
Preparation
(solution,
emulsion,
suspension)
2. Capsule
86
Basic Composition Of Tablet
Excipient (Inactive Ingredients)
No
Name/Function
Example
Source
1
Diluent
-To make up the
volume
Dibasic calcium phosphate
Synthetic chemical
Lactose
Animal (bovine)
Microcrystalline cellulose
Plant
Binder
-To give sufficient
Hardness
Povidone
Synthetic chemical
Starch paste
Plant
Acacia
Plant
Disintegrant
-To break up tablets in
smaller fragments
Starch and its derivative
Plant
Methyl cellulose
Synthetic chemical
Sodium croscarmellose
Synthetic chemical
2
3
87
Basic Composition Of Tablet
Excipients (Inactive Ingredients)
No
Name/Function
Example
Source
4
Lubricant
-To reduce friction
between die wall and
tablet wall
Magnesium Stearate
Animal (Bovine or Porcine)
or Plant
Talc
Mineral
Calcium Stearate
Animal (Bovine or Porcine)
or Plant
Glidant
-To maintain the flow
property
Magnesium Stearate
Animal (Bovine or Porcine)
or Plant
Aerosil
Mineral
Talc
Mineral
Anti-adherent
-To break up tablets in
smaller fragments
Aerosil
Mineral
Talc
Mineral
Coloring agent
-To improve elegance
Dye
Plant, synthetic chemical or
mineral
Lake pigment
Plant
5
6
7
88
Basic Composition Of Tablet
Excipients (Inactive Ingredients)
No
Name/Function
Example
Source
8
Sweetening Agent
-To reduce bitter taste
of drug
Aspartame
Synthetic Chemical
Mannitol
Plant
9
Flavoring agent
Volatile oil
-To reduce or mask bad
odor of drug
Plant
10
Preservative
-Antimicrobial and
antifungal agent
Plant
Methyl paraben
89
Basic Composition Of Capsule
Excipient (Inactive Ingredients)
No
Name/Function
Example
Source
1
Diluent
-To make up the
volume
Magnesium carbonate
Synthetic Chemical
Lactose hydrous/anhydrous
Animal (Bovine)
Cellulose
Plant
Binder
-To give sufficient
Hardness
Corn starch
Plant
Potato starch
Plant
Disintegrant
-To break up tablets in
smaller fragments
Sodium starch glycolate
Plant
Croscarmellose sodium
Synthetic chemical
Preservative
-Antimicrobial and
antifungal agent
Methyl paraben
Plant
2
3
4
90
Basic Composition Of Capsule
Excipients (Inactive Ingredients)
No
Name/Function
Example
Source
5
Lubricant
-To reduce friction
between die wall and
tablet wall
Magnesium Stearate
Animal (bovine or porcine)
or Plant
Talc
Mineral
Surfactant
-To maintain the flow
property
Sodium docusate
Synthetic chemical
Sodium lauryl sulfate
Plant
6
91
Basic Composition Of Capsule
8
Shell (Capsule)
-To enclose medicine
Basic Composition
Source
1) Gelatin powder
Animal (bovine or porcine)
2) Plasticizer – in soft
capsule only (glycerin)
Animal (bovine or porcine)
or synthetic chemical
3) Water
-
4) Preservative
(Propionic, benzoic,
sorbic and their sodium
salt)
Synthetic chemical
5) Colorant (Titanium
oxide, caramel, acid
fuchsine B, chlorophylls,
etc)
Minerals, plant or synthetic
chemical
6) Opaquing agent
(Titanium dioxide)
Mineral
92
93
Basic Composition Of Liquid Preparation For Oral Use
(Suspension, Solution And Emulsion)
Excipient (Inactive Ingredients)
No
Name/Function
1
Buffer
Citric acid
-To resist any change in Acetic acid
pH
Borate
Plant
Isotonicity modifiers
-To provide suitable
isotonicity
Sodium chloride
Mineral
Dextrose
Plant
Viscosity
enhancement
-Manipulate flowabilty
of the liquid
Acacia
Plant
Carbomer
Synthetic chemical
Preservative
-Antimicrobial and
antifungal agent
Alcohol (Ethanol)
Plant or synthetic
chemical
Acids (Benzoic, sorbic acid)
Plant or synthetic
chemical
Benzalkonium chloride
Synthetic chemical
2
3
4
Example
Source
Plant
Mineral
94
Basic Composition Of Liquid Preparation For Oral Use
(Suspension, Solution And Emulsion)
Excipient (Inactive Ingredients)
No
Name/Function
Example
Source
5
Antioxidant
-To prevent oxidation
of liquid preparation
Ascorbic acid
Natural chemical
Tocopherol
Natural chemical
Sweetener
-To mask the bitter
taste of drug
Sucrose
Plant
Mannitol
Plant
6
7
Flavoring agent
Volatile oil
-To reduce or mask bad
odor of drug
Plant
8
Emulsifier
-Stabilizes an emulsion
Sodium dodecyl sulfate
Organic chemical
Propofol
Organic chemical
95
MALAYSIA HALAL CERTIFICATION
INTERNATIONAL HALAL CERTIFICATION BODIES