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					                      FaceFresh Product Quality Specifications

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INN (International Non-property Name): Povidone Iodine
Chemical Name: Poly(vinylpyrrolidone) Iodine [PVP-Iodine]
Or called as: 2-Pyrrolidinoe, 1-ethenyl-, homopolymer, compd. with iodine.
Or called as: 1-Vinyl-2-pyrrolidinone polymer, compound with iodine
(C6H9NO)n.xI

Specifications
    10% Povidone Iodine powder, it is brown color fine powder, and it is a
complex of Iodine with Povidone. It contains not less than 9.0 percent and not
more than 12.0 percent of available iodine (I), calculated on the dried basis.

Analyze Control Methods and Acceptance Limits

    Identification:

        A: Add 1 drop of a solution (1 in 10) to a mixture of 1ml of starch TS
        and 9 ml of water: a deep blue color is produced.

        B: Spread 1 ml of a solution (1 in 10) over an area of about 20 x 20 cm
        on a glass plate, and allow to air-dry at room temperature in an
        atmosphere of low humidity overnight: a brown, dry, non-smearing film
        is formed, and it dissolves readily in water.

    Available Iodine Measurement: Place about 5 g of Povidone-Iodine,
    accurately weighed, in a 400-ml beaker, and add 200 ml of water. Cover the
    beaker, and stir by mechanical means at room temperature for not more than1
    hour to dissolve as completely as possible. Titrate immediately with 0.1 N
    sodium thiosulfate VS, adding 3 ml of starch TS as the endpoint is
    approached. Perform a blank determination, and make any necessary
    correction. Each ml of 0.1 N sodium thiosulfate is equivalent to 12.69 mg of I.

    Iodine ion: Weighed accurately 0.5 g of 10% of 10% PVP-Iodine, dissolve in
    100 ml of distilled water in a 250 ml conical flask. Add dropwisely sodium
    bisulfate TS until the color of iodine has disappeared. Add accurately 25 ml
    of silver nitrate (0.1 mol/L) VS and 10 ml of nitric acid and mix well. Titrate
    the excess of silver nitrate with ammonium thiocynate (0.1 mol/L) VS to
    light brick red color, using 0.5 ml of ferric ammonium sulfate TS as the
    indicator. Perform a blank determination and make necessary correction.
    Each ml of silver nitrate (0.1 mol/L) VS is equivalent to 12.69 mg of I, the


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   percentage of iodide ion is obtained by subtracting the percentage of
   available iodine under Assay from the percentage of total iodine calculated
   on the dried basis. It shall be not more than 6.6%, calculated on the dried
   basis.

   Measurement of loss on drying of 10% PVP-Iodine: Dry 5 g, weighed
   accurately, at 105 degree centigrade for 4 hours, weigh and continue to weigh,
   once every hour until the difference between two successive weighings at 1
   hour intervals is not greater than 5.0 mg. It shall lose not more than 8.0% of
   its weight.

   Nitrogen content: Weigh accurately about 0.5 g of 10% PVP Iodine and carry
   out the method for determination of Nitrogen. It shall be not less than 9.5%
   and not more than 11.5% of N, calculated on the dried basis.

   Residue on ignition: (USP25/281), negligible, from 2g.

   Heavy metals: USP25 Method II (231): 0.002%.

      ITEMS                            SPECIFICATIONS &
      Characteristics identification   Red-brown, crystalline powder
      Loss on drying                   ≤8%
      Residue on ignition              Negligible (from 2 g)
      Iodine ion                       ≤6.6%
      Heavy metals                     ≤20 ppm
      Nitrogen                         9.5 – 11.5%
      Assay for available iodine       9.0 - 12.0%

Auxiliary Materials

Chemical Names:

   Citric Acid Monohydrate
   Potassium Iodide
   Disodium Hydrogen Phosphate Dodecahydrate
   Sterile Purified Water

Specifications: Citric Acid Monohydrate, Potassium Iodide and Disodium
Hydrogen Phosphate Dodecahydrate are Analytic Reagents (AR Grade)

Analyze Control Methods and Acceptance Limits:



                                       2
Citric Acid Monohydrate [CAS No.: 5949-29-1]
C6H8O7.H2O

Readily carbonizable substance – Transfer 1,0 g, powdered for the test, to a 22 X
175-mm test tube previously rinsed with 10 ml of sulfuric acid TS. Agitate until
solution is complete, and immerse in a water bath at 90 ±for 60 ±minutes,
keeping the level of the acid below the water during the entire period. Cool the
tube in running water, and transfer the acid to a color-comparison tube; the color
of the acid is not darker than that of a similar volume of Matching Fluid K in a
matching tube, the tubes being observed vertically against a white background.

Sulfate: To 10 ml of a solution (1 in 100) add 1 ml of barium chloride TS to
which has been added 1 drop of hydrochloric acid: no turbidity is produced.

Limit of oxalate: Neutralize 10 ml of a solution (1 in 10) with 6N ammonium
hydroxide, add 5 drops of 3N hydrochloric acid, coo and add 2 ml of calcium
chloride TS; no turbidity is produced.

Organic volatile impurities: Method IV (467) of USP25: meets the requirements.

Assay: Place about 3 g of Citric Acid in a tared flask, and weigh accurately.
Dissolve in 40 ml of water, add phenolphthaleinn TS. And titrate with 1 N
sodium hydroxide VS. Each ml of 1 N sodium hydroxide is equivalent to 64.04
mg of C6H8O7.

       ITEM                            SPECIFICATION
       Purity                          ≥99.90% min.
       Appearance                      White fine powder
       Solubility                      Pass the test
       Insoluble substance residue     ≤0.005%
       Residue on ignition             ≤0.02%
       Chloride (Cl)                   ≤0.0005%
       Sulfate (SO4)                   ≤0.005%
       Phosphate (PO4)                 ≤0.001%
       Oxalate                         ≤0.05%
       Ca                              ≤0.005%
       Fe                              ≤0.0005%
       Cu                              ≤0.0005%
       Arsenic                         ≤3 ppm
       Pb                              ≤0.0005%



                                        3
Disodium Hydrogen Phosphate Dodecahydrate
Na2HPO4.12H2O
[CAS No: 7558-79-4]
OSHA Regulatory Status: 29 CFR1910.1200 and 40 CFR117, 302

Analytic Method and Standard: UDC 661.833.45 and China National Standard
[GB 1263 – 86]

Measurement of Na2HPO4.12H2O: Weigh 5 g of sample accurately to four digits
after decimal point (0.0002 g), dissolve in 100 ml of water in which it does
contain CO2. Follow the procedure of [HG 3-1014-76], use 0.5N TS to titrate to
pH value equal 4.4.

Calculation equation of Na2HPO4.12H2O (in percentage, X):

X = [(V x c x 0.3581)/m] x 100

V = volume of TS Sulfuric acid solution used (in ml)
c = concentration of standard solution of sulfuric acid used, in N
m = the amount of sample applied, in gram
0.3581 = grams of Na2HPO4.12H2O per each mN

Measurement of chloride (Cl): Weigh 1 g of sample, dissolve in 25 ml of water,
add 2 ml of 5N nitric acid and 1 ml of 0.1 silver nitrate, shake and mix well, stay
for 10 minutes. No turbidity is allowed over the standard.

Measurement of sulfate (SO4): Weigh 1 g of sample, dissolved in 80 ml of water,
use 25% hydrochloric acid solution adjust pH to 5 –6, dilute to 100 ml and mix
well. Take 20 ml, add 0.5 ml 25%chloric acid solution, add into 1.25 ml of
solution I, dilute up to 25 ml, stay for five minutes. No turbidity is allowed over
the standard.

[Preparation of solution I: weigh accurately 0.02 g of K2SO4, dissolve in 100 ml
of 30% (V/V) ethanol solution, take 2.5 ml, mix with 10 ml of 25% BaCl solution,
stay accurately for one minute (mix before using).]

       ITEM                             SPECIFICATION
       Purity                           ≥99.00%
       Appearance                       White crystalline powder
       Solubility                       Pass the test
       Insoluble substance residue      ≤0.005%
       Chloride (Cl)                    ≤0.001%

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       Sulfate (SO4)                    ≤0.01%
       Nitride (N)                      ≤0.002%
       Potassium (K)                    ≤0.01%
       Fe                               ≤0.0005%
       Arsenic (As)                     ≤0.0005
       Heavy metal                      ≤0.0005%


Potassium Iodide (KI) [CAS No.: 7681-11-0]

Identification: A solution of it meets the requirements of the Potassium (191 of
USP) and for Iodide (USP25).

Alkalinity: Dissolve 1.0 g in 10 ml of water, and add 0.1 ml of 0.1N sulfuric acid
and 1 drop of phenolphthalein TS; no color is produced.

Loss on drying (USP25/731): Dry it at 105 ℃ for 4 hours, it loses not more than
1.0% of its weight.

Iodate: Dissolve 1.1 g in sufficient ammonia- and carbon dioxide-free water to
obtain 10 ml of solution, and transfer to a color-comparison tube. Add 1 ml of
starch TS and 0.25 ml of 1.0N sulfuric acid, mix, and compare the color with that
of a control containing in a similar volume, 100 mg of Potassium Iodide, 1 ml of
standard 100 ml iodate solution [prepare by diluting 1 ml of potassium iodate
solution (1 in 2,5000) with water to 100 ml]. 1 ml of starch TS. And 0.25 ml of
1.0N sulfuric acid. Any color produced in the solution of the test specimen does
not exceed that in the control; not more than 4ug per g is found.

Limit of nitrate, nitrite, and ammonia: To a solution of 1 g in 5 ml of water
contained in a test tube of about 40-ml capacity, add 5 ml of 1N sodium
hydroxide and about 200 mg aluminum wire. Insert a pledget of purified cotton in
the upper portion of the test tube and place a piece of moistened red litmus paper
over the mouth of the tube. Heat the test tube and its contents in a steam bath for
15 minutes; no blue coloration of the paper is discernible.

Thiosulfate and barium: Dissolve 0.5 g on 10 ml of ammonia- and carbon
dioxide-free water, and add 2 drops of 2N sulfuric acid; no turbidity develops
within one minute.

Heavy metals (USP25/231): Dissolve 0.5 g in 25 ml of water; the limit is 0.001%.

Organic volatile impurities: Method I (USP25/467): meets the requirements.


                                         5
Assay: Dissolve about 500 mg of Potassium Iodide sample, accurately weighed,
in about 10 ml of water, and add 35 ml of hydrochloric acid. Titrate with 0.05M
potassium iodate VS until the dark drown solution which is produced becomes
pale brown. Add 2 to 3 drops of amaranth TS. And continue the titration slowly
until the red color just changes to yellow. Each ml of 0.05 M potassium iodate is
equivalent to 16.60 mg of KI.


       ITEM                             SPECIFICATION
       Purity                           ≥99.00%
       Appearance                       White crystalline powder
       Solubility                       Pass the test
       Insoluble substance residue      ≤0.010%
       Iodate and Iodine (IO3)          ≤0.0020%
       Chloride and bromide (Cl)        ≤0.02%
       Sulfate (SO4)                    ≤0.005%
       Phosphate (PO4)                  ≤0.002%
       Na                               ≤0.10%
       Mg                               ≤0.002%
       Ca                               ≤0.002%
       Fe                               ≤0.0003%
       Arsenic (As)                     ≤0.00002%
       Ba                               ≤0.002%
       Heavy metal (Pb)                 ≤0.0005%
       Reducing substance               Pass test


Sterile Purified Water [H2O]


It is Purified Water steriled and contains no antimicrobial agent.

Sterility: It meets the requirements of UPS(25, 71)

рH: Its pH is between 5.0 and 7.0 in a solution containing 0.3 ml of saturated
potassium chloride solution per 100 ml of test specimen.

Ammonia: For containers having a fill volume of less than 50 ml, dilute 50 ml of
it with 50 ml of High-Purity Water, and use this dilution as the test solution;


                                         6
where the fill volume is 50 ml or more, use 100 ml of it as the test solution. To
100 ml of the test solution add 2 ml of alkaline mercuric-potassium iodide TS:
any yellow color produced immediately in not darker than that of a control
containing 30 μ g of added NH, in 100 ml of High-Purity Water. This
corresponds to a limit of 0.6 mg per liter for containers having a fill volume of
less than 50 ml and 0.3 mg per liter where the fill volume is 50 ml or more.

Calcium: To 100 ml add ml of ammonium oxalate TS: no turbidity is produced.

Carbon dioxide: To 25 ml of calcium hydroxide TS: the mixture remains clear.

Chloride: To 20 ml in a color-comparison tube add 5 drops of nitric acid and 1 ml
of silver nitrate TS, and gently mix: any turbidity formed within 10 minutes is not
greater than that produced in a similarly treated control consisting of 20 ml of
High-Purity Water, containing 10 μg of Cl (0.5 mg per liter), viewed downward
over a dark surface with light entering the tubes from the sides.

Sulfate: To 100 ml add 1 ml of barium chloride TS; no turbidity is produced.

Oxidizable substances: To 100 ml, add 10 ml of 2N Sulfuric acid, and heat to
boiling. For Sterile Purified Water in containers having a fill volume of less than
50 ml, add 0.4 ml of 0.1 N potassium permanganate, and boil for 5 minutes;
where the fill volume is 50 ml or more, add 0.2 ml of 0.1 N potassium
permanganate, and boil for 5 minutes. If a precipitate forms, cool in an ice bath to
room temperature, and filter through a sintered-glass filter: the pink color does
not completely disappear.


Finished Product Controls

1. Specifications of Finished Product: The product is a solution of Povidone
Iodine, it is a homogeneous dark-brown color solution, contains not less than 85.0
percent and not more than 120.0 percent of the labeled amount of iodine (I), its
pH value is in the range of 5.0 – 7.0, the total Available Iodine: 85.0 – 120.0%. It
is in 15 ml plastic bottle which is packed in paper box, each bottle contains 10 ml
of the solution.

  Chemical characteristics: It is a solution of Povidone Iodine, contains not less
than 85.0 percent and not more than 120.0 percent of the labeled amount of
iodine (I).

    A. pH value: 5.0 – 7.0


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    B. The total Available Iodine: 85.0 – 120.0%

    C. The pH Value: between 5.0 and 7.0

  Product packing: It is in 15 ml plastic bottle. The color of bottle has to be dark,
  not transparent to light and sunlight. Each plastic bottle contains 10 ml of the
  solution.

2. Analyze Control Methods and Acceptance Limits

    Assay of Available Iodine: Transfer to a 100-ml beaker an accurately
    measured volume of the solution, equivalent to about 50 mg of iodine, and
    add water to make a total volume of not less than 30 ml. Titrate immediately
    with 0.02 N sodium thiosulfate VS, determining the endpoint
    potentiometrically, using a platinum-calomel electrode system. Perform a
    blank determination, and make a necessary correction. Each ml of 0.02 N
    sodium thiosulfate is equivalent to 2. 538 mg of I.

    The pH Value: USP25 (791) between 5.0 and 7.0

    Volume measurement of bottling: Each bottling machine is calibrated
    accurately before actual production run. The accuracy range is within ±3%.

    Inspection of leaking of product’s bottle: It is mandatory required that each
    batch of every bottle of product after sealing has to be placed in the upside
    down position for overnight in order to observe whether there is leaking
    happened. Next morning, if there is no leak of the bottle, then get packed.

3. Stability Studies verifying Determined Shelf Life (on mg. basis) and
validations concerning analytic test methods.

It is required by the Laws of federal Ministry of Health of The People’s Republic
of China that each disinfectant product must pass the test of stability study of the
product, before obtaining the required license and selling to public.

According to the rule and regulation stipulated by federal Ministry of Health that
are published in their manual of federal guideline and standards for disinfectant
manufacturer, AND Decree (No. 27, issued on March 28, 2002 – “Decree of The
Disinfectant Management and Surveillance Method”) of Ministry of Health of
The People’s Republic of China. There are standardized stability study methods
for disinfectant products, including iodine-contained disinfectant products.




                                         8
For iodine-contained disinfectant products, there are three (3) legally
recognizable testing methods:

  Stability study at 54 ℃ for two weeks (Decree No. 27; 4.2 and 4.2.4). If the
  product passes this test, the manufacturer can legally claim its product has the
  Shelf Life of one (1) year.

  Stability study at 37 ℃,> 75% damp for three months (Decree No. 27; 4.2.4).
  If the product passes this test, the manufacturer can legally claim its product
  has the Shelf Life of two (2) years.

  Real time stability study (Decree No. 27; 4.2.5). The product is placed at
  laboratory room, no temperature and humidity control (place in room naturally)
  for the period time (such as three years) requested by the manufacturer. If the
  product passes this test, the manufacturer can legally claim its product has the
  Shelf Life of three (3) years, for instance.

The evaluation standard of stability of Iodine-contained disinfectant products is
that it shall be less than 10% of loss of active ingredient by comparing the before-
and after- concentration measurements of the active ingredient (Available Iodine).

Our test process and method is as follows:

For the solution: Randomly collect necessary quantity of sample of the solution
and store in 125-ml dark brown color glass bottles for the testing. Divide them
into three groups. Group A of sample (four bottles, 120 ml per each bottle) is for
the immediate test. Group B of sample (four bottles, 120 ml per each bottle) is for
the test at the end of the design period. Group C of sample (ten bottles, 120 ml
per bottle) is for the future real time stability study.

Assay of Available Iodine: Transfer to a 100-ml beaker an accurately measured
volume of the solution, equivalent to about 50 mg of iodine, and add water to
make a total volume of not less than 30 ml. Titrate immediately with 0.02 N
sodium thiosulfate VS, determining the endpoint potentiometrically, using a
platinum-calomel electrode system. Perform a blank determination, and make a
necessary correction. Each ml of 0.02 N sodium thiosulfate is equivalent to 2. 538
mg of I.

For the finished product:

After packing, send laboratory 800 sealed bottles of the Lot. Divide them into
three groups. Group A of sample (200 bottles, 10 ml per bottle) is for the
immediate test. Group B of sample (200 bottles, 10 ml per bottle) is for the test at

                                         9
the end of the design period. Group C of sample (400 bottles, 10 ml per bottle) is
for real time stability study.

Assay of Available Iodine: Open the necessary amount of bottles by mechanical
means. Collect the sample and transfer to a 100-ml beaker an accurately
measured volume of the solution, equivalent to about 50 mg of iodine, and add
water to make a total volume of not less than 30 ml. Titrate immediately with
0.02 N sodium thiosulfate VS, determining the endpoint potentiometrically, using
a platinum-calomel electrode system. Perform a blank determination, and make a
necessary correction. Each ml of 0.02 N sodium thiosulfate is equivalent to 2. 538
mg of I.




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