To Whom It May Concern,...To Whom It May Concern, INTRODUCTION: The following analyses are conducted...

To Whom It May Concern,

INTRODUCTION: The following analyses are conducted for Guanidine Hydrochloride,

product code GH3220, in accordance with the Guanidine Hydrochloride Testing Methods DCN:

16-000493 v.5.0 and Certificate of Analysis DCN: 16-001146 v.3.0. Specific details for the

procedures were also obtained from Spectrum Two UATR SOP DCN: 16-001330 v.3.0, MP50

Melting Range Operation and Calibration SOP DCN: 16-001332 v.4.1, NexION 350X ICP-MS

SOP DCN: 16-001923 v.2.0, RNase (Ribonuclease) Assay SOP DCN: 16-000366 v.2.0, DNase

(Endonuclease) Assay SOP DCN: 16-000365 v.2.0, DNase (Exonuclease) Assay SOP DCN: 16-

000511 v.2.0, and Protease Assay SOP DCN: 16-000512 v.3.0.

ABSORBANCE (6M) REFER TO CERTIFICATE OF ANALYSIS: 1.

1.1. Prepare a 6M solution of the specified sample (Solution may be scaled as needed).

1.1.1. Accurately weigh 57.2g of sample into a 100 mL volumetric flask and Q.S. to the mark

with purified water.

1.1.2. Mix thoroughly.

1.2. Refer to Lambda 25 UV/Vis Operation and Calibration to determine the absorbance of the

sample.

APPEARANCE AND COLOR White / Crystals: 2.

2.1. Place 25-50g of the sample in a clean, dry glass beaker.

2.2. In an area with sufficient lighting, view the sample from all sides.

2.3. The sample should be white in color and characteristic of crystals. If the sample does not

conform to these specifications, notify the appropriate personnel immediately.

ASSAY (Guanidine Basis) 99.5% Min: 3.

3.1. Standardize 0.1N Perchloric by hand as per Standardization of Titrants.

3.2. NOTE: Perform a blank determination utilizing all reagents below minus the product, there

will be a blank for standardization and a blank for the assay.

3.3. Accurately weigh 0.35g of Guanidine hydrochloride into an appropriate beaker.

3.4. Add stir bar.

3.5. Add 140mL of Glacial Acetic Acid.

3.6. Add 20mL of 5% mercuric acetate in glacial acetic acid solution.

3.7. Add 0.1mL of 100mg/10mL crystal violet in glacial acetic acid solution.

3.8. Dissolve sample while stirring.

3.9. Record Temperature of the Perchloric Acid.

3.10. Titrate to a blue green end point with 0.1N Perchloric Acid.

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3.10.1. Note: Due to the high volumetric coefficient of expansion of glacial acetic acid a

temperature correction factor is included in the analysis as Cf. Cf = [1+1.07x10-3

(Ts-Ti)]

3.10.1.1. Ts = temperature at standardization

3.10.1.2. Ti = temperature at sample titration

%𝐺𝑢𝑎𝑛𝑖𝑑𝑖𝑛𝑒 = (𝐸𝑃𝑆𝑎𝑚𝑝𝑙𝑒 − 𝐸𝑃𝐵𝑙𝑎𝑛𝑘)(𝑁 𝑜𝑓 𝑃𝑒𝑟𝑐ℎ𝑙𝑜𝑟𝑖𝑐 𝐴𝑐𝑖𝑑)(9.55318)(𝐶𝑓)

(𝑆𝑎𝑚𝑝𝑙𝑒 𝑤𝑒𝑖𝑔ℎ𝑡 (𝑔)) − ((𝑆𝑎𝑚𝑝𝑙𝑒 𝑤𝑒𝑖𝑔ℎ𝑡 (𝑔))(%𝐿𝑂𝐷))

ENZYME ACTIVITY None Detected: 4.

4.1. Refer to RNase (Ribonuclease) Assay SOP for instrument set up and use.

4.1.1. Assay

4.1.1.1. Prepare sample (typically 2% or 0.2 g/mL) utilizing the table below:

Sample Solution Preparation

Weight Sterile Water Volume

0.03g 1.5mL

4.1.1.2. Prepare standards utilizing the table below:

RNase Standards Preparation

Final Concentration (Unit/µL) Volume of RNase Solution1 (µL) Volume of RNase Buffer (µL)

1x10-3

2.5 of RNase Solution2

1997.52

0.2x10-3

200 of 1x10-3

800

0.2x10-4

100 of 0.2x10-3

900

0.2x10-5

100 of 0.2x10-4

900

0.2x10-6

100 of 0.2x10-5

900

0.2x10-7

100 of 0.2x10-6

900 110 mg/mL

2Volumes will vary based on the concentration reported on the RNase vendor’s C of A. Use the following

calculations:

Step 1: (Vendor C of A(𝑈

𝑚𝑔)) x 10(

𝑚𝑔

𝑚𝐿) = X(

𝑈

𝑚𝐿)

1x10-3 Unit/µL = 1 (Unit/mL)

Step 2: Volume of RNase Solution (µ𝐿) =1 𝑈𝑛𝑖𝑡/𝑚𝐿 x 2000µ𝐿

X𝑈

𝑚𝐿(from Step 1)

)

4.1.1.3. Make a Reaction Mix, where Y represents the total number of tubes to be

prepared, as follows:

RNase Reaction Mix

Amount Solution

(Y+1)x1μL E.coli Total RNA Substrate (1 mg/mL)

(Y+1)x1μL RNase 10X Reaction Buffer

(Y+1)x3μL Sterile Water

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1.0GH3220 Guanidine Hydrochloride, Bio Excipient Test Methods

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4.1.1.4. Label an appropriate number of microcentrifuge tubes and add previously

prepared solutions to each of the tubes as follows:

Blank Test Solution 10-4 10

-5 10-6 10

-7 Control

Tube # 1 2 3 4 5 6 7

Reaction Mix (µL) 5 5 5 5 5 5 5

Sterile Water (µL) 5 - - - - - 5

Test Solution (µL) - 5 - - - - -

Control Enzyme1

(µL)

- - 51

51 5

1 51 -

1Appropriately diluted RNase. (Note, for instance, that 5 microliters of 0.2 x 10

-4 units of RNase IA

per microliter represents 1 x 10-4

units of RNase IA.)

4.1.1.5. Mix thoroughly and immediately place the Control onto ice or into a

temperature monitored refrigerator.

4.1.1.6. Incubate all others at 37ºC for 4 hours.

4.1.1.7. Cool tubes on ice or in a temperature monitored refrigerator for approximately

5 minutes. Centrifuge all tubes for 1 minute. To each tube, add 4 microliters of

Gel Loading Buffer. Vortex thoroughly. Centrifuge for 1 minute.

4.1.1.8. Utilize Electrophoresis to analyze the samples.

4.2. Refer to DNase (Endonuclease) Assay SOP for instrument set up and use.

4.2.1. Assay

4.2.1.1. Prepare each sample (typically 2% or 0.2 g/mL) utilizing the table below:



0.03g 1.5mL


DNase: Endonuclease Standards Preparation

Final Concentration (Unit/µL) Volume of DNase I Enzyme (µL) Volume of DNase I Buffer (µL)

0.2 2 of DNase I 21201

0.2x10-2

10 of 0.2 990

0.2x10-4

10 of 0.2x10-2

990

0.2x10-5

100 of 0.2x10-4

900

0.2x10-6

100 of 0.2x10-5

900

0.2x10-7

100 of 0.2x10-6

900 1Volume of DNase I buffer for DNase I enzyme at 20,000 Units

4.2.1.3. Dilute Substrate prior to preparing reaction mix, as follows:

DNase: Endonuclease Substrate Preparation

Final Concentration (μg/ μL) Volume of pBR 322 DNA Substrate (µL) Volume of TE Buffer (µL)

0.1 8 12

4.2.1.4. Prepare a Reaction Mix, where Y represents the total number of tubes to be


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Endonuclease Reaction Mix

Amount Solution

(Y+1)x1μL Diluted pBR 332 DNA Substrate

(Y+1)x1μL DNase 10X Reaction Buffer (Endonuclease)




Blank Test Solution 10-4

10-5

10-6

10-7

Control

Tube # 1 2 3 4 5 6 7

Reaction Mix (µL) 5 5 5 5 5 5 5

Sterile Water (µL) 5 - - - - - 5


Control Enzyme1 (µL) - - 5

1 5

1 5

1 5

1 -

1Appropriately diluted DNase I. (Note, for instance, that 5 microliters of 0.2 x 10

-4 Units DNase

per microliter represents 1 x 10-4

Units DNase.)








4.3. Refer to DNase (Exonuclease) Assay SOP.

4.3.1. Assay




0.03g 1.5mL

4.3.1.2. Prepare standards utilizing the table below.

DNase: Exonuclease Standards Preparation

Final Concentration

(Unit/ μL )

Volume of Bal-31

Nuclease Enzyme (µL)

Volume of

Nuclease Buffer (µL)

0.2x10-2

2 of Bal-311

998

0.2x10-3

100 of 0.2x10-2

900

0.2x10-4

100 of 0.2x10-3

900 1Bal-31 Nuclease Enzyme concentration of 1000 U/mL



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Exonuclease Reaction Mix

Amount Solution

(Y+1)x2μL ʎDNase/ Hind III Fragment (0.1 μg/ μL)

(Y+1)x2μL DNase 5X Reaction Buffer (Exonuclease)




Blank Test Solution 10-2 10

-3 10-4 Control

Tube # 1 2 3 4 5 6

Reaction Mix (µL) 5 5 5 5 5 5

Sterile Water (µL) 5 - - - - 5

Test Solution (µL) - 5 - - - -

Control Enzyme1

(µL)

- - 51

51 5

1 - 1Appropriately diluted Nuclease Bal-31. (Note, for instance, that 5 microliters of 0.2 x 10

-2 units of Bal-

31 per microliter represents 1 x 10-2

units of Bal-31.)








4.4. Refer to Protease Assay SOP.

4.4.1. Assay:




0.03g 1.5mL


Protease Standards Preparation

Final Concentration

(ng of Proteinase K)

Volume of Proteinase K

Solution (μL)

Volume of Sterile Water

(μL)

Stock 10 of 3 mg/mL 990

2 20 of Stock 980

5 50 of Stock 950

10 100 of Stock 900

25 250 of Stock 750

50 500 of Stock 500



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Protease Reaction Mix

Amount Solution

(Y+1)x0.2mL Protease Substrate Solution containing Azocasein

(Y+1)x0.05mL Protease 10X Reaction Buffer

4.4.1.4. All Standards and Samples will be prepared in duplicate.



Blank Test Solution 50 ng2 25 ng 10 ng 5 ng 2 ng

Tube # 1 2 3 4 5 6 7

Sterile Water (µL) 250 - 250 250 250 250 250


Control Enzyme1

(µL)

- - 51

51

51

51

51

Reaction Mix (µL) 250 250 250 250 250 250 250 1Appropriately diluted Proteinase K from the Protease Reaction Mix Table.

2The 50ng standard is not required for reporting as None Detected. The preparation can be used to

quantify the presence of Protease at concentrations above 25ng.

4.4.1.5.1. Mix thoroughly.

4.4.1.5.2. Ensure the water bath is at least ¾ full. Incubate at 37ºC for 16-18

hours.

4.4.1.5.3. Cool tubes in a temperature monitored refrigerator or on ice for

approximately 5 minutes. Centrifuge for 5-10 seconds. Add to each

tube 0.67 mL of 10% TCA and mix thoroughly.

4.4.1.5.4. Cool in a temperature monitored refrigerator or on ice for 30-60

minutes. Centrifuge for 5-10 seconds. Rotate tubes 180º in the

centrifuge. Centrifuge for 1 minute.

4.4.1.5.5. Carefully remove 0.65 mL of the supernatant and add it to 0.65 mL

of 0.5 N NaOH and mix thoroughly.

4.4.1.5.6. Utilize UV/Vis to analyze absorbance and calculate R2.

IDENTIFICATION (IR) Passes Test: 5.

5.1. For UATR analysis, follow Spectrum Two UATR SOP for Instrument Set-Up and Use.

5.1.1. Perform a background scan prior to use each day and after every ten samples.

5.1.2. Each analyst must run a Reference Standard prior to analyzing a product. A Reference

Standard may be compared to multiple lots of the corresponding product on that day.

5.1.3. Enter the Lot Number, Expiration Date, Date of Analysis, and Analyst Initials in the

Sample ID.

5.1.4. Place the Sample on the UATR crystal using a static free scoop.

5.1.5. Align the swinging arm with the crystal and apply force by turning the green arm

clockwise.

5.1.6. Press “Scan” on the top Toolbar. The program will preview the sample. Turn the green

arm until the Force Gauge is approximately 125, or until the noise has subsided.

5.1.7. Once the Force Gauge is adjusted, press “Scan”.

5.1.8. Once the scan is complete, release the swinging arm by turning it counterclockwise.

5.1.9. Clean the UATR crystal and the swinging arm with methanol and a Kim Wipe.

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5.1.10. If the correlation is above 0.95. the comparison will be reported with Pass as the result.

5.1.11. Analyze sample as-is.

INSOLUBLE MATTER (WATER INSOLUBLES) 0.15% max.: 6.

6.1. Accurately weigh 50.0g of sample and transfer to a 150mL beaker.

6.2. Add 25mL of room temperature purified water. If necessary, utilize a Teflon encapsulated

magnetic stirring bar and electric stir plate to dissolve sample.

6.3. Dry a Gooch crucible and filter paper at 105° 2°C for 1 hour. Cool in ambient air for 15

minutes and weigh.

6.4. Filter sample solution through the Gooch crucible using a suitable vacuum pump.

6.5. Rinse sample vessel and crucible filter with at least 150mL of purified water.

6.6. Dry the crucible at 105° 2°C for 1 hour. Cool in ambient air for 15 minutes and weigh.

% 𝐼𝑛𝑠𝑜𝑙𝑢𝑏𝑙𝑒𝑠 = 𝑅𝑒𝑠𝑖𝑑𝑢𝑒 𝑊𝑒𝑖𝑔ℎ𝑡 (𝑔) ∗ 100

𝑆𝑎𝑚𝑝𝑙𝑒 𝑊𝑒𝑖𝑔ℎ𝑡 (𝑔)

LOSS ON DRYING @ 105°C 0.5% max.: 7.

7.1. Dry a LOD vial in an oven at 105 ± 2˚C for at least 1 hour. Cool for 15 minutes in a desiccator,

weigh, and record results.

7.2. Place the vial on the analytical balance and tare the dried vial. Weigh 2.0 g of sample and

record results.

7.3. Dry for 4 hours at 105˚C. Cool for 15 minutes in desiccator.

7.4. Retain Sample for Assay, dried basis.

7.5. Reweigh and calculate the % LOD.

% 𝐿𝑜𝑠𝑠 𝑜𝑛 𝐷𝑟𝑦𝑖𝑛𝑔 = 𝐼𝑛𝑖𝑡𝑖𝑎𝑙 𝑆𝑎𝑚𝑝𝑙𝑒 𝑊𝑒𝑖𝑔ℎ𝑡 (𝑔) − 𝐹𝑖𝑛𝑎𝑙 𝑆𝑎𝑚𝑝𝑙𝑒 𝑊𝑒𝑖𝑔ℎ𝑡 (𝑔) ∗ 100

𝐼𝑛𝑖𝑡𝑖𝑎𝑙 𝑆𝑎𝑚𝑝𝑙𝑒 𝑊𝑒𝑖𝑔ℎ𝑡 (𝑔)

MELTING RANGE 184 – 188°C: 8.

8.1. Refer to MP50 Melting Range Operation and Calibration SOP for Instrument Set-Up and Use.

8.1.1. Reduce sample to a fine powder in a mortar and pestle prior to drying the sample

8.1.2. Dry the sample over a suitable desiccant for a minimum of 16 hours, or dry at a

temperature and time according to the product’s LOD procedure.

8.1.3. Place the prepared sample into a capillary tube. A clean packing rod can be used to push

residual sample down the capillary tube but should not enter approximately 2 cm from

the closed end of the capillary tube. The sample should then be packed down to a height

of 2.5-3.0mm by gentle tapping on a solid surface.

8.1.4. Allow the instrument to reach the approximate start temperature for the current method.

The instrument will beep once the initial temperature is reached.

8.1.5. Place the capillary tube containing the sample in the melting point apparatus.

8.1.6. Ensure that the packed sample is within the “min” and “max” lines on the instrument.

8.1.7. Do not force the capillary tube(s) into the apparatus; they should drop right in.

8.1.8. Select the correct method on the home screen, according to the product being analyzed.

8.1.9. Press the start button.

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8.1.10. When prompted, entire the lot number into the “Analysis Comments”.

8.1.11. Using the on-screen camera display follow these steps:

8.1.11.1. Record the initial temperature as the temperature at which the sample begins to

collapse in on itself.

8.1.11.2. Record the final temperature as the temperature at which the sample is

completely liquidated.

8.1.11.3. Bubbles may form with in the sample during melting. If the sample is

completely liquidated and there are still bubbles present in the sample, the

sample is still considered completely melted.

NITRATE 0.01% max.: 9.

9.1. Sample Preparation (Solution A):

9.1.1. Add 0.40g of sample to 2.0mL of water, dilute to 50mL with brucine sulfate reagent

solution, and mix thoroughly.

9.2. Control Preparation (Solution B):

9.2.1. Add 0.40g of sample to 2.0mL of 10 ppm standard nitrate solution and dilute to 50mL

with brucine sulfate reagent solution, and mix thoroughly.

9.3. Blank Preparation (Solution C):

9.3.1. Transfer 50 mL of the Brucine Sulfate reagent solution to a 50mL volumetric flask.

9.4. Procedure:

9.4.1. Heat the three solutions in a preheated (boiling) water bath for 10 min. Cool rapidly in an

ice bath to room temperature. Utilizing the Lambda 25, dispense blank solution C into

one of the two matched 10mm cuvettes and place into the second cell holder (closest to

the front of the instrument) in order to complete a “100% / 0A Baseline (Auto Zero)”.

Remove blank solution C and scan sample solution A and control solution B respectively

at 410nm. Calculate the nitrate content as:

%𝑁𝑂3 =𝐴𝑈𝑆𝑜𝑙𝑢𝑡𝑖𝑜𝑛 𝐴

𝐴𝑈𝑆𝑜𝑙𝑢𝑡𝑖𝑜𝑛 𝐵 − 𝐴𝑈𝑆𝑜𝑙𝑢𝑡𝑖𝑜𝑛 𝐴∗ % 𝑚𝑎𝑥𝑖𝑚𝑢𝑚 𝑎𝑙𝑙𝑜𝑤𝑎𝑏𝑙𝑒

pH (6M) @ 25°C 4.5-6.0: 10.

10.1. Prepare a 6M solution of the specified sample (Solution may be scaled as needed). Solution

previously prepared for Absorbance (6M) may be utilized.




10.1.3. Ensure the pH curve is stable before obtaining result.

10.1.4. Follow the appropriate SOP for calibration and pH measurement.

RESIDUE ON IGNITION 0.05% max.: 11.

11.1. Turn on muffle furnace and allow temperature to stabilize at 600ºC. Follow muffle furnace

SOP and calibration procedure for operation.

11.2. Utilize the 10 inch forceps to insert and remove a crucible into the furnace.

11.3. Ignite the quartz crucible at 600 ± 50 °C for 30 minutes. Cool in a desiccator for one hour and

30 minutes and weigh.

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11.4. Weigh 5.0g sample in the previously ignited quartz crucible. Moisten the sample with 2 mL of

sulfuric acid.

11.5. Volatilize the sample with a Bunsen burner. Keep the sample an appropriate distance from the

flame, so that the sample does not boil over and sample is not lost.

11.5.1. The rate of heating should be such that from ½ to 1 hour is required to volatilize the

sample.

11.5.2. Continue using the Bunsen burner to heat the sample until all excess sulfuric acid has

been volatilized.

11.6. Ignite in the muffle furnace at 600 ± 50 °C for 30 minutes or until all carbon has been removed.

11.7. Cool in the desiccator for a minimum of an hour and a half and reweigh.

%𝑅𝑂𝐼 = 𝑅𝑒𝑠𝑖𝑑𝑢𝑒 𝑊𝑒𝑖𝑔ℎ𝑡 (𝑔) ∗ 100

𝑆𝑎𝑚𝑝𝑙𝑒 𝑊𝑒𝑖𝑔ℎ𝑡 (𝑔)

SOLUBILITY (6M) Passes Test: 12.

12.1. Prepare a 6M solution of the specified sample (Solution may be scaled as needed). Solution

previously prepared for Absorbance (6M) may be utilized.




12.2. Observe from all angles. Sample solution should be clear and colorless and comparable to the

color and turbidity of a sample of water visually.

SULFATE 0.01% max.: 13.

13.1. Sample Preparation:

13.1.1. Weigh 1.0g of sample and transfer to a 50 mL Nessler Color Comparison Tube. Dissolve

in 40mL of purified water.

13.2. Standard Preparation:

13.2.1. Prepare a standard solution by pipetting 0.052 mL of 0.020 N H2SO4 in a 50 mL Nessler

Color Comparison Tube. QS to 40 mL with purified water.

13.3. Procedure:

13.3.1. To both the sample and standard solutions, add 1 mL of 3 N HCl, 3 mL of Barium

Chloride TS and QS to the line.

13.3.2. Cover with parafilm and mix by inversion.

13.3.3. Compare turbidity 10 minutes after addition of the barium chloride to the sample and

standard solutions.

13.4. Any turbidity produced in the sample solution should not exceed that produced by the standard

when viewed from above against a black surface.

13.5. If turbidity of the sample solution exceeds that of the standard notify the QC Manager

immediately.

TRACE METALS REFER TO CERTIFICATE OF ANALYSIS: 14.

14.1. Refer to NexION 350X ICP-MS SOP for Instrument Set-Up and Use.

14.1.1. Sample Preparation:

14.1.2. General Notes:

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14.1.2.1. Before use, all plasticware that is not rated as “metal-free”, should first be

rinsed with purified water, rinsed with 15% Nitric Acid, and then rinsed again

with purified water. Plasticware rated as “metal-free” may be used as-is.

14.1.2.2. Glass should be avoided as it has high potential for metal and mineral

contaminations.

14.1.2.3. Standard and sample solutions should be prepared in 50mL centrifuge tubes.

14.1.3. 1% Nitric Acid

14.1.3.1. Measure 14.5 mL of Trace Metal Grade Nitric Acid and transfer to a rinsed

plastic 1000 mL volumetric flask. QS to 1000 mL with purified water.

14.1.4. 15% Nitric Acid

14.1.4.1. Dilute approximately 110 mL of Trace Metal Grade Nitric Acid to 500 mL


14.1.4.2. The solution is only used to rinse glassware and plasticware.

14.1.5. BioSpectra Daily Method:

14.1.5.1. Sample Solutions:

14.1.5.1.1. Weigh 0.10g of sample on an analytical balance. Add 100 uL of

Environmental Standard Mix 6 and QS to 50.0 with 1% Nitric Acid.

14.1.5.2. Standard Curve Preparation:

14.1.5.2.1. 2 ppm Stock

14.1.5.2.1.1. Weigh 1.00 g of Instrument Calibration Standard 2 and QS

to 50.0 g with 1% Nitric Acid.

14.1.5.2.2. 100 ppb Stock

14.1.5.2.2.1. Weigh 2.50 g of 2 ppm Stock and QS to 50.0 with 1%

Nitric Acid.

14.1.5.2.3. Blank

14.1.5.2.3.1. Pipette 100 uL of Environmental Standard Mix 6 into the

centrifuge tube. QS to 50.0 g with 1% Nitric Acid.

14.1.5.2.4. 1 ppb Standard

14.1.5.2.4.1. Pipette 0.50 mL of the 100 ppb Stock, add 100 uL of

Environmental Standard Mix 6 and QS to 50.0 g with 1%

Nitric Acid.

14.1.5.2.5. 2 ppb Standard (also used as a Continuing Check Verification

Sample (CCV))



Nitric Acid.




Nitric Acid.



Environmental Standard Mix 6 and QS to 50.0g with 1%

Nitric Acid.

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If there are any questions or concerns, please feel free to contact [email protected].

Sincerely,

Cassie Baun

Compliance Specialist

BioSpectra, Inc.

100 Majestic Way

Bangor, PA 18013

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To Whom It May Concern,...To Whom It May Concern, INTRODUCTION: The following analyses are conducted...

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