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PHARMACEUTICAL E
MODULE
SEMINAR (A) 7
FINALS - DISCUSSION
DISPENSING AND INCOMPATIBILITIES
o Combining topical products for use in
Compounding and manufacturing is important, but dermatology: for example, the use of a certain
oftentimes difficult, to distinguish between compounding antibiotic with a specific anti-inflammatory agent
and manufacturing
PREPARATION VS PRODUCTS
C O M P O U N D I N G  The United States Pharmacopeia (USP) uses the term
 Preparation, mixing, assembling, packaging or o PREPARATION to refer to compounded
labeling of a drug or device prescriptions
 Result of a practitioner’s prescription drug order or o PRODUCTS to refer to manufactured
initiative based on the pharmacist/patient/prescriber pharmaceuticals.
relationship in the course of professional practice or
the purpose of, as in incident to research, teaching or COMPOUNDED PRESCRIPTION
chemical analysis and not for sale dispensing.  A prescription with two or more components,
 With the Direction of the prescriber requiring compounding or mixing the components.

TYPES OF COMPOUNDED PRESCRIPTION

M A N U F A C T U R I N G
 ISOLATED PRESCRIPTION – one that the
 Production, preparation, propagation, conversion pharmacist is not expecting to receive nor expecting
or processing of a drug or device, either directly or to receive again.
indirectly, by extraction from substances of natural
o Not the usual to be received by a pharmacist
origin or independently by means of chemical or  ROUTINE PRESCRIPTION – one that the pharmacist
biological synthesis, and includes any packaging or
may expect to receive in the future on a routine basis,
repackaging of the substance(s) or labeling or
and there may be some benefit to products quality to
relabeling of its container, and the promotion and
standardize preparations like this. (preparation
marketing of such drugs or devices.
protocols on file).
 Includes the preparation and promotion of
 BATCH PREPARED PRESCRIPTION – one of which
commercially available products from bulk compounds multiple identical units are prepared as a single
for resale by pharmacies, practitioners, or other
operation in anticipation of a receipt of prescription
persons. o Large amount of compounded prescription
 Bulk, upsize that is anticipated by a pharmacist.
WHAT IS EXTEMPORANEOUS COMPOUNDING? FACTORS TO CONSIDER IN COMPOUNDING
 It is defined as the timely preparation of a drug
product according to a physician’s prescription, a STABILITY
drug formula, or a recipe in which amounts of the o Consider:
ingredients are calculated to meet the needs of a  Chemical
particular patient or group of patients.  Physical
 PURPOSE: prepare an individualized drug  Microbiological stability
treatment for a patient based on an order from a duly o Assign BEYOND-USE DATE – the time and date
licensed prescriber. after which the compounded product should not
 The Fundamental difference between compounding be stored nor transported.
and manufacturing is the existence of o For NON STERILE compounded drug product
pharmacist/prescriber/patient relationship that packaged in tight, light, resistant containers
controls the compounding of the drug preparation. and stored at controlled room temperature:
o Compounded drugs are not for resale but,  For non-aqueous liquids and solid
rather, are personal and responsive to the formulation (manufactured drug product is
patient’s immediate needs. the source of active ingredients)
 Although the need for extemporaneous compounding  Beyond-use date is not later than 25% of the
has decreased due to the availability of standardized time remaining until the product expiration
commercial drug products, the need for date or 6 months, whichever is earlier.
extemporaneous preparations continues especially in o For PRODUCT WITH A USP OR NF
cases such as: SUBSTANCE as the source of active
o Dispensing pediatric medications ingredients
o It may be necessary to dilute standard adult The beyond-use date ≤ 6 months
strengths of drugs to obtain measurable doses.

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<795> BEYOND-USE-DATE  Other balances may be used, provided they give

FORMULATION BUD MAXIMUM equivalent or better accuracy – like electronic
A NON AQUEOUS formulation 6 months maximum single-pan balance.
(eg, a capsule without water in it) BUD  Class A - this is used for medicines or powders
 CLASSIFICATION – balance
An ORAL formulation containing 14 days under
 Single-beam (equal-arm or unequal arm),
water refrigeration
 Compound lever
(eg, suspension that undergone maximum BUD
 Torsion
reconstitution )
 And electronic
A TOPICAL containing water 30 days Maximum
(eg, ointment) BUD
PRESCRIPTION BALANCES
 Uses the tautwire frame or torsion principle
o For all other formulations  Class III balance
The beyond-use date is not later than intended
 Have a maximum maintenance sensitivity of six (6)
duration of therapy or 30 days, whichever is
mg with no load and with full load, used to weigh
earlier unless there is a supporting valid quantities up to 60 g
scientific stability information applicable to the
specific preparation o Pharmacists an technicians should be familiar
o Commonly recommended STORAGE
with:
TEMPERATURES:  CAPACITY – maximum weight that can be
FREEZER between (-) 25˚C and (-) 10˚C
placed on the balance pan.
o There are some medications or  SENSITIVITY – the smallest weight that
Chemicals are stored in the freezer. It
gives a perceptible change in the indicating
is important to a drugstore to have a element.
Bioref.  READABILITY
COLD TEMPERATURE: not exceeding 8˚C
 In ELECTRONIC BALANCE, the smallest
REFRIGERATOR thermostatically controlled weight increment that can be read on the
between 2˚C and 8˚C digital display of the balance (e.g. 0.001 g)
COOL TEMPERATURE – between 8˚C and
 On DOUBLE-PAN BALANCE, the smallest
15˚C weight increment determined by the value
CONTROLLED ROOM TEMPERATURE –
of a hash-mark on the graduated dial or
thermostatically controlled between 20˚C and weigh beam (e.g., on metric scale of the
25˚C with allowed excursions between 15˚C
dial, each mark = 0.01 g)
to 30˚C  PRECISION - Reproducibility of the weighing
measurement as expressed by a standard
COMPOUNDING SUPPORT deviation.
TRAINING AND EXPERIENCE OF PHARMACIST  ACCURACY - Closeness of the displayed
weight as measured by the balance, to the
EQUIPMENT true weight.
o Based on the type and extent of the services
one chooses to provide.
���%
MINIMUM WEIGHABLE QUANTITY
o Equipment surfaces that come in contract with
�%
ingredients or compounded preparations should MWQ = SR
not be reactive, additive, or sorptive so that the
Example:
purity of the preparation is not compromised.
1. Calculate the MWQ with no more than a 5% error for a

���%
balance with a sensitivity requirement of 10 mg.
LAMINAR FLOW HOOD
�%
 for aseptic compounding of sterile solutions. MWQ = 10 mg = 200 mg
Practice problem: Calculate the MWQ with no more than
REFRIGERATOR a 3% error for a balance with a sensitivity requirement of
to maintain temperatures as specified in the USP.
���%
 2.5 mg.

�%
BALANCES 2.5mg X = 83.3mg
 An instrument for determining the relative weights
of substances WEIGHING DISH
 Should be selected correctly for the specific task at  usually made of aluminum or polystyrene plastic, with
hand. capacity of 5 to 250ml.
 Used skillfully,  Very handy and securely contain substances
 Protected from damage, and checked periodically being weighed
o OHAUS should be checked everyday  Useful for weighing liquids because they
 Balances – CLASS A OR CLASS III prescription have rigid sides.
balances  More expensive than weighing papers

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or commercial PHARMACEUTICAL INGREDIENTS

grade
Food grade Used for food STIFFENING AGENT
Cosmetic grade Used for cosmetics o Agents that increase the thickness or hardness
of the preparation
PHARMACEUTICAL INGREDIENTS o It is used for semisolid alcohol
o Ex. Cetyl alcohol, paraffin, white wax, yellow
FLAVORANT wax
 imparts pleasant flavor and often odor to a
preparation. SUPPOSITORY BASE
 FLAVORING METHODOLOGY o A vehicle for drug substances formulated into
o BLENDING - used for fruit flavors with sour, bitter, suppositories
sweet o Ex. Cocoa butter (most common suppository
o OVERSHADOW - used when longer and stronger base), witepsol, wecobee, PEG(Polyethylene
o PHYSICAL - used in insoluble glycol) mixtures
o CHEMICAL - used for the process of absorption
o PHYSIOLOGICAL - anesthetize the unpleasant SURFACTANT
taste o Agents which reduces interfacial tension
o Is a contracted word for surface active agents
o Ex. Benzalkonium chloride, polysorbate 80,
Taste Flavor
SLS, TWEENS and SPANS
BITTER Chocolate, anise o SLS - causes the allergenicity
SWEET Fruit, berry, vanilla o TWEENS - Polyoxyethylene sorbitan
SOUR Citrus, rootbeer, anise, strawberry o SPANS - Sorbitan esters
SALTY Butterscotch, maple, peach, melon raspberry
SUSPENDING AGENT
SOLVENTS o Increases viscosity and reduces rate of
sedimentation
1. WATER o Used for suspension
o Universal solvent, can dissolve both ionic and o Ex. Carboxymethyl cellulose, Methyl cellulose,
polar solutes bentonite, acacia, agar, veegum, tragacanth
o Salts are soluble in water
SWEETENING AGENT
2. AROMATIC WATER o Imparts sweetness
o Most commonly used as flavoring agents o Ex. Mannitol, saccharin, sorbitol, sucrose
o SORBITOL - is a flavoring agent and
o Easily driven off from the solution
o Easily salted-out by electrolytes also a humectant in toothpaste.
 It is also a reduce sugar
o Different from spirits; spirits (alcohol)
o SACCHARIN - the oldest sweetening
3. SYRUP agent which is artificial
o Used as Solvent, flavorant, medicinals
TONICITY AGENTS
4. GLYCERIN o Render solutions similar in osmotic dextrose
o Best solvent for phenols, iodine, boric acid, characteristics to physiologic fluids.
borates, tannic acid and cresol o The preparation should be isotonic with the body
fluids to prevent pain, that is why tonicity agents
5. ALCOHOL are added
o Good solvent for organic compounds such as
alkaloids, glycosides, camphor, phenol, tannins, TABLET EXCIPIENT
o ESSENTIAL COMPONENTS - the most important
balsams resins and for some inorganic salts
since they will impart satisfactory
6. ELIXIRS characteristics to the formulation
o Not preferred for salts because it accentuates the o DILUENT
saline taste o BINDERS
o Aromatic elixir, NF contains approximately 22% o DISINTEGRANTS
alcohol o COMPRESSION AIDS
o LUBRICANTS - this is used to prevent
7. OILS friction between the particles
o PMSC (peanut, corn, sesame and mineral oil) o GLIDANTS - it is used for the flowability of
solvents for IM preparation the powders
o OLEIC ACID is used as a base for alkaloids
o OLIVE OIL for sprays and drops

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o ANTIADHERANTS - used to make the  PH

powder not sticked to the cavity wall in  SOLUBILITY OF THE CHEMICALS
which the tablet is produced  TASTE (FOR ORAL SOLUTIONS)
o SUPPLEMENTARY COMPONENTS - are added  PACKAGING NEED
in order to give the desired physical
characteristics SOLUBILITY
o COLOR  usually stated as the number of parts (by volume)
o FLAVOR that will dissolve one part (by weight or by volume of a
o SWEETENING AGENTS liquid) of the substance.
 Solubility = g of solute/ml of solvent
SOLUTIONS
 Are liquid preparations that contain one or more TERMS OF SOLUBILITY PARTS OF SOLVENT
chemical substances dissolved in a suitable solvent
or mixture of mutually miscible solvents. VERY SOLUBLE <1
 Most solutions are unsaturated with the solute. FREELY SOLUBLE 1-10
 The strengths of which are usually expressed in terms SOLUBLE 10-30
of % strength, although for very dilute preparation, SPARINGLY SOLUBLE 30-100
ratio strength are used. SLIGHTLY SOLUBLE 100-1000
 This is homogenous VERY SLIGHTLY SOLUBLE 1000-10000
INSOLUBLE >10000
ADVANTAGES
o Completely homogenous dose
o Immediate availability of drug for absorption and TECHNIQUES TO INCREASE DISSOLUTION RATE
distribution  Applying heat
o Provides flexible dosage form  Reducing the particle size of the solute
 May be administered by any route of  Utilizing of a solubilizing agent (Potassium Iodide,
administration sodium Iodide)
 Can be taken by or administered to patients who  Subjecting the ingredients to rigorous agitation.
cannot swallow tablets or capsules
 Doses are easily adjusted FACTORS THAT AFFECT SOLUBILITY
 Particle size
DISADVANTAGES  pH - Increase pH, Increase solubility,
o Drugs and chemical are less stable when in solution o Acid & base - water soluble
than when in dry, solid form  Extent of agitation - More agitation, faster to dissolve
o Some drugs are not soluble in solvents that are  temperature
acceptable for pharmaceutical use o POSITIVE HEAT - Drugs absorb heat when they
o Drugs with undesirable taste require special are dissolved
additives or techniques to mask the taste when in o NEGATIVE HEAT - Chemicals in which it
solution decreases solubility when there is an increase
temperature.
GENERAL RULES IN PREPARING SOLUTIONS o Ex. Calcium Hydroxide
 Each drug or chemical is dissolved in the solvent in
which it is most soluble. METHODS OF PREPARATION OF SOLUTIONS
 If an alcoholic solution of a poorly water soluble drug
is used, the aqueous solution is added to the alcoholic A. SIMPLE SOLUTION
solution.  This can be done in stirring. This is prepared by
 The salt form of the drug is used. dissolving the solute in a suitable solvent. It can
 Flavoring or sweetening agents are prepared ahead. be by heat or by stirring
 The proper vehicle must be selected.  Ex. Iodine Solution

FACTORS TO CONSIDER IN PREPARING SOLUTIONS B. SOLUTION BY CHEMICAL REACTION

 STABILITY  Ex. Calcium Carbonate (CaCO3) + Lactic acid =
o Stability of the active drug and the preparation as a Calcium lactate
whole is considered.
o Instability such as: C. SOLUTION BY EXTRACTION
Color fading
Flavor loss TYPES OF SOLUTIONS
Cloudiness
Precipitation NON-STERILE SOLUTIONS
Microbial growth o Oral solutions
o Topical solutions
o Other solutions

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GLYCERINS  Sterilize by filtration through a sterile 0.2-um filter or

 Glycerins or glycerites are solutions or mixtures of by dry heat (170 C for 1.5 hrous). Package in sterile
medicinal substances in not less than 50% by weight vials and label
of glycerin.
Example 1. A. Medication order Progesterone 5 g Benzyl
STERILE SOLUTIONS alcohol 10 mL Sesame oil q.s. 100 mL

NASAL SOLUTIONS DISPERSED SYSTEMS

o Administered as nose sprays or nose drops  Consist of particulate matter known as dispersed
o ISOTONIC to nasal secretions and buffered to phase, dispersed throughout a continuous or
normal pH range as nasal fluids dispersion medium.
 Dispersed systems are classified according to particle
IRRIGATION SOLUTIONS size
o Sterile, non-pyrogenic solutions use to wash or o MOLECULAR DISPERSION - <1 nm true
bathe surgical incisions, wounds, or body solutions
tissues o COLLOIDAL DISPERSION - 1nm – 0.5 um colloid
o COARSE DISPERSION - > 0.5 um suspension &
COMMONLY USED PARENTERALS emulsion

0.9% Sodium Chloride Isotonic 154 mEq Sodium COARSE DISPERSIONS

(green) pH 5.7 154 mEq Chloride  SUSPENSION: Solid drug in liquid vehicle
 EMULSION: Liquid drug in liquid vehicle:
Shorthand Notation: NS o Oil-in-water emulsions (o/w)
Ringer’s Injection, Isotonic 147 mEq Sodium o Water-in-oil (w/o)
U.S.P. pH 5.8 4 mEq Potassium
4 mEq Calcium SUSPENSIONS
155 mEq Chloride  Liquid preparations that consist of solid particles
dispersed throughout a liquid phase in which the
Lactated Ringer’s Isotonic 130 mEq Sodium particles are not soluble.
Shorthand Notation: LR pH 6.6 4 mEq Potassium  Suspensions are liquid preparations of drugs
3 mEq Calcium containing finely divided drug particles distributed
109 mEq Chloride uniformly throughout the vehicle.
28 mEq Sodium  It could appear cloudy that is why shaking is required
Lactate (provides 9
calories/liter) ORAL RECITATION
*DEXTROSE - red What is the Difference Between Solution & Suspensions?

PHARMACEUTICAL SOLUTIONS

AQUEOUS SWEET &/OR NONAQUEOUS

VISCID
 Douches  Syrups  Elixirs
 Enemas  Honeys  Spirits
 Gargles  Mucilages  Collodions Eventually the particles sink to the bottom to form
 Mouthwashes  Jellies  Glycerins SEDIMENT
 Nasal washes  Liniments
 Juices  Oleo Vitamin PROBLEMS IN FORMULATING SUSPENSION
 Sprays
 Otic solutions AGGREGATION
 Inhalations o Small particles aggregate into clumps or
floccules.
ORAL RECITATION o it increases the rate of sedimentation and may
 Dissolve the progesterone in the BENZYL prevent pourability.
ALCOHOL(used as a preservative, however it
should not be given to larger volume parenterals) SEDIMENTATION
 LARGE VOLUME PARENTERALS - liters
o The velocity of fall of a suspended particle in a
 SMALL VOLUME PARENTERALS - 30 ml or 50
vehicle of a given density is greater for larger
ml can use preservative particles than is for smaller particles.
 Add sufficient sesame oil to make 100mL o Greater the particle size, the greater the settling of
the particles

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SETTLING AND AGGREGATION Examples

 The suspension shall form loose networks of flocs that NATURAL Tragacanth (1-3%), acacia gum
settle rapidly, do not form cakes and are easy to POLYSACCHARIDES (10%), starch, agar, guar gum,
resuspend. carrageenan and sodium alginate
 Settling and aggregation may result in formation of (1-2%)
cakes (suspension) that is difficult to resuspend or SEMI-SYNTHETIC  Methylcellulose (Cologel ®,
phase separation (emulsion) POLYSACCHARIDES Celacol ®) – 1-7%
 Hydroxyethylcellulose
FLOCCULATED VS DEFLOCCULATED (Natrosol 250®)
 Sodium
FLOCCULATED DEFLOCCULATED carboxymethylcellulose
Particles form loose Particles exist in suspension (Carmellose sodium®)
aggregates. as separate entities.  Microcrystalline cellulose
Rate of sedimentation is Rate of sedimentation is (Avicel®)
high, as particles settle as slow, as each particle  Carboxymethylcellulose –
a floc. settles separately and 1-3%
particle size is minimal CLAYS Bentonite (6%) and magnesium
A sediment is formed A sediment is formed aluminium silicate (Veegum®) –
rapidly slowly. (6%)
The sediment is packed The sediment eventually SYNTHETIC  Carbomer (Carboxyvinyl
loosely and possesses a becomes very closely THICKENERS polymer, Carbopol®)
scaffold-like structure. packed, due to the weight of  Colloidal silicon dioxide
the upper layers of (Aerosil®, Cab-o-sil®)
sedimenting material.  Polyvinyl alcohol (PVA)
Particles do not bond Repulsive forces between MISCELLANEOUS GELATIN used as a suspending
tightly to each other and a particles are overcome and a THICKENERS agent and a viscosity increasing
hard, dense cake does hard cake is formed that is agent
not form. difficult, if not impossible to *CARBOPOL - is used to form gel
redisperse.
The sediment is easy to The supernate also remains CONTAINERS FOR SUSPENSIONS
redisperse, so as to cloudy, even when settling is  Pack in WIDE MOUTH amber bottle for internal use
reform the original apparent. and for external use.
suspension  There should be an adequate air space above the
The suspension is The suspension has a liquid to allow shaking and ease of pouring.
somewhat unsightly, due pleasing appearance, as  A medicine spoon or oral syringe should be given
to rapid sedimentation and the suspended material when the suspension is for oral use.
the presence of an remains suspended for a o Household tablespoon is not used in medicine
obvious, clear supernatant relatively long time.
region. COMPOUNDING
 Triturate the solid into finest particle
SUSPENDING AGENTS  For, indiffusible solids, choose the appropriate
 FIVE BROAD CATEGORIES: suspending agent
o Natural polysaccharides  Flavoring agents and preservatives should be
o Semi-synthetic polysaccharides selected and added if the product is intended for oral
o Clays use.
o Synthetic thickeners  The vehicle containing the suspending agent is added
o Miscellaneous compounds in divided portions while mixing
 Never filter
ORAL RECITATION:  The product is brought to required volume using the
1. What is the rationale behind the addition of vehicle.
suspending agents?  Dispense with a shake well label when necessary.
 To increase the viscosity of the vehicle,
thereby slowing down sedimentation LABELING
2. Give 2 suspending agents suitable for oral
 A “shake well: label should be placed on the label of
preparations. the final product
 Acaicia & Tragacanth
 If for external use – indicate the label

GENERAL CLASSES OF SUSPENSION

 Oral suspension
 Externally applied suspension
 Parenteral suspension

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*4 parts of oil; 2 part of water; 1 part of gum  Sorbitan monostearate (Span 60)
 Sorbitan monopalmitate (Span 40)
ORAL RECITATION:  Sorbitan monolaureate (Span 20)
A. Acacia emulsions – o/w  Polyoxyethylene sorbitan tristearate (Tween 65)
o Primary emulsions (4:2:1) (o:w:a)  Polyoxyethylene sorbitan trioleate (Tween 85)
o Ratio for volatile oils – 3:2:1 or 2:2:1  Polysorbate 80 (Tween 80)
 Polysorbate 40 (Tween 40)
 Describer how to prepare primary emulsion using Dry
 Polysorbate 20 (Tween 20)
gum method (continental)
 There is a clicking sound
 Gum + Oil + water (hard and fast trituration)
 Describe how to prepare primary emulsion using Wet
gum method (English)
 Acacia + wetting agent + water + oil (slowly)

EMULSIFYING AGENTS
 USES:
o Act by lowering the interfacial tension
o Provide a barrier around the droplet as they form
and prevent coalescence of droplets
 The problem with the emulsion is when it form
coalescence this will be irreversible

TYPES OF EMULSIFIERS
ACCORDING TO FUNCTION

TRUE OR PRIMARY EMULSIFIERS

 capable of stabilizing emulsions by themselves.
 It can be used alone
ORAL RECITATION:
Required HLB for mineral oil to form o/w type is 12 : w/o is
STABILIZERS OR AUXILIARY AGENTS 5
 used in combination with primary emulsifiers
Rx Mineral Oil 50 mL
 It cannot stand alone
Span 60 qs
Tween 40 qs
ACCORDING TO SOURCE Cherry syrup 40 mL
NATURAL P. water qs ad 120 mL
 may be derived from vegetable and animal sources
Prepare o/w type emulsion
SYNTHETIC EA: Spans (w/o) (HLB 3-6) and tweens (o/w) (HLB 8-18)
 are anionic, cationic, or nonionic
Oral preparations (amount needed): 2-5% emulsifier for
ANIONICS – monovalent, polyvalent and organic
liquid emulsions
soaps (carboxyl, sulfate, sulfonate)
CATIONIC – positively charged quaternary and
1. Compute for the total amount of EA needed:
pyridinium nitrogen (benzalkonium Chloride)
5% x 120mL = 6g 5% = 0.05
NONIONIC – (polyhydroxyl groups) Spans (1-9)
2. What is the HLB of Span 60 4.7
Tweens (11-20) 3. What is the HLB of Tween 40 15.6
4. Compute for the Amount of Spans and tweens (use
HLB allegation alternate)
 Emulsifiers and surfactants are characterized by the
hydrophilic-lipophilic balance ((HLB): a relative
ratio of polar and non-polar groups in the surfactant
 HLB 1 to 3: Antifoams
 HLB 4 to 6: Water-in-Oil Emulsifiers
 HLB 7 to 9: Wetting and spreading agents
 HLB 8 to 18: Oil-in-Water Emulsifiers
 HLB 13 to 15: Detergents *Place the HLB in decreasing order
 HLB 10 to 18: Solubilizers CHOOSING EMULSIFYING AGENTS

NON IONIC SURFACTANT EMULSIONS ACACIA

 Not viscosity inducing agents  forms a good, stable emulsion of low viscosity
 Sorbitan monooleate (Span 80)  It tends to cream easily, is acidic
 Stable at a pH range of 2-10

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