POTASSIUM Gluconate 468 mg TABLETS NPN#...

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JAA NATURALS CANADA 510 Rowntree Dairy Road, Building J, Woodbridge, ON L4L 8H2 Tel: 905-851-7885 Fax: 905-856-5838 Email: [email protected] Website: www.jaapahrm.com D 1 issoluon characteriscs to bioavailability of a solid dosage will vary with factor of formulaon or by manufacturing process. It can be use to idenfy bioequivalence problems and can serve as a signal of bioequivalence as well. Jaapharm dissoluon systems are state of the art fully automated in Canadian pharma industry. 1 Vessels creang gastro-dissoluon condions measuring drug levels to the plasma from intesne bypassing the stomach (gastro track) resulng in no side effects. Auto sampler with 8 designated tubes for each vessel collecng sample at assigned intermissions and delivering to Agilant UV-Visible Spectrophotometre. Agilant UV-Visible Spectrophotometre analysing each sample instantly and send results to the PC system. PC Systems linked to dissoluon systems. 5 HPLC systems for method development. 2 3 4 5 2 3 4 6 Reasons Why: All Raw materials, Finished products are tested in house & released by QA before use. Products are Mfg. at Jaapharm CGMP** facility in Canada License 300109 issued by NHPD***. Finished products are also tested for dissolution under USP Monograph in house. All products are on stability, dissolution & microbial testing program. Packaging is done at Jaapharm CGMP** facility in Canada License 300109 issued by NHPD***. POTASSIUM Gluconate 468 mg TABLETS NPN# 8005804 Smallest Potassium Gluconate 468 mg coated tablet in Canada. Highest single dose allowed by Health Canada (NHPD). *HDFC - High Density Force Compression **CGMP- Current Good Manufacturing Practices according to Health Canada ***NHPD - Natural Health Products Directorate (Health Canada) Actual Size Potassium is used as a treatment or prevenon of hypokalemia (potassium depleon). For treatment of digitalis toxicity. Used as Potassium replacement therapy. Used as Electrolyte replenisher. Halal & Kosher, no animal by-product nor gelan, glun, sweetner, colour, preservave or oil. Thin layer HDFC* enteric coating. It’s Chloride free which makes it more suitable for high blood pressure & heart condition patients. JAA K 2 ® ®

Transcript of POTASSIUM Gluconate 468 mg TABLETS NPN#...

Page 1: POTASSIUM Gluconate 468 mg TABLETS NPN# …jaapharm.com/products/human/POTASSIUM_TABLETS_(JAA_K2).pdf · JAA NATURALS CANADA 510 Rowntree Dairy Road, Building J, Woodbridge, ON L4L

JAA NATURALS CANADA510 Rowntree Dairy Road, Building J, Woodbridge, ON L4L 8H2Tel: 905-851-7885 Fax: 905-856-5838 Email: [email protected] Website: www.jaapahrm.com

D

1

issolution characteristics to bioavailability of a solid dosage will vary with factor of formulation or by manufacturing process. It can be use to identify bioequivalence problems and can serve as a signal of bioequivalence as well. Jaapharm dissolution systems are state of the art fully automated in Canadian pharma industry.

1 Vessels creating gastro-dissolution conditions measuring drug levels to the plasma from intestine bypassing the stomach (gastro track) resulting in no side effects.Auto sampler with 8 designated tubes for each vessel collecting sample at assigned intermissions and delivering to Agilant UV-Visible Spectrophotometre.Agilant UV-Visible Spectrophotometre analysing each sample instantly and send results to the PC system. PC Systems linked to dissolution systems.

5

HPLC systems for method development.

2

3

4

5

2 3 4

6 Reasons Why:

All Raw materials, Finished products are tested in house & released by QA before use.

Products are Mfg. at Jaapharm CGMP** facility in Canada License 300109 issued by NHPD***.

Finished products are also tested for dissolution under USP Monographin house.

All products are on stability, dissolution & microbial testing program.

Packaging is done at Jaapharm CGMP** facility in CanadaLicense 300109 issued by NHPD***.

POTASSIUM Gluconate 468 mg TABLETS NPN# 8005804

Smallest Potassium Gluconate 468 mgcoated tablet in Canada. Highest single dose allowedby Health Canada(NHPD).

*HDFC - High Density Force Compression**CGMP- Current Good Manufacturing Practices according to Health Canada***NHPD - Natural Health Products Directorate (Health Canada)

Actual Size

Potassium is used as a treatment or prevention of hypokalemia (potassium depletion).For treatment of digitalis toxicity. Used as Potassium replacement therapy.Used as Electrolyte replenisher. Halal & Kosher, no animal by-product nor gelatin, glutin, sweetner, colour, preservative or oil.

Thin layer HDFC* enteric coating. It’s Chloride free which makes it more suitable for high blood pressure & heart condition patients.

JAA K 2 ®

®

Page 2: POTASSIUM Gluconate 468 mg TABLETS NPN# …jaapharm.com/products/human/POTASSIUM_TABLETS_(JAA_K2).pdf · JAA NATURALS CANADA 510 Rowntree Dairy Road, Building J, Woodbridge, ON L4L

6 Reasons Why:

All Raw materials, Finished products are tested in house & released by QA before use.

Products are Mfg. at Jaapharm CGMP** facility in Canada License 300109 issued by NHPD***.

Finished products are also tested for dissolution under USP Monographin house.

All products are on stability, dissolution & microbial testing program.

Packaging is done at Jaapharm CGMP** facility in CanadaLicense 300109 issued by NHPD***.

POTASSIUM Gluconate 468 mg TABLETS NPN# 8005804

Smallest Potassium Gluconate 468 mgcoated tablet in Canada. Highest single dose allowedby Health Canada(NHPD).

*HDFC - High Density Force Compression**CGMP- Current Good Manufacturing Practices according to Health Canada***NHPD - Natural Health Products Directorate (Health Canada)

Actual Size

Potassium is used as a treatment or prevention of hypokalemia (potassium depletion).For treatment of digitalis toxicity. Used as Potassium replacement therapy.Used as Electrolyte replenisher. Halal & Kosher, no animal by-product nor gelatin, glutin, sweetner, colour, preservative or oil.

Thin layer HDFC* enteric coating. It’s Chloride free which makes it more suitable for high blood pressure & heart condition patients.

JAA K 2

0.00%

10.00%

20.00%

30.00%

40.00%

50.00%

60.00%

70.00%

80.00%

90.00%

100.00%

110.00%

0 Month(L)18158 & (L)18159

24 Months(L)18158 & (L)18159

45 Months(L)18158 & (L)18159

DISSOLUTION RESULT

ASSAY RESULT ASSAY RESULT

DISSOLUTION RESULT

POTASSIUM GLUCONATE TABLETS STABILITY SUMMARY

(L)1

8158

(L)1

8159

(L)1

8158

(L)1

8158

(L)1

8158

(L)1

8159

(L)1

8159

(L)1

8159

Now Available :

JAA K2

POTASSIUM

Gluconate 468 mg

78 mg or 2 mEq of Potassium

(L)1

8158

(L)1

8158

(L)1

8159

(L)1

8159

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JAA NATURALS CANADA510 Rowntree Dairy Road, Building J, Woodbridge, ON L4L 8H2Tel: 905-851-7885 Fax: 905-856-5838 Email: [email protected] Website: www.jaapahrm.com

®

Page 3: POTASSIUM Gluconate 468 mg TABLETS NPN# …jaapharm.com/products/human/POTASSIUM_TABLETS_(JAA_K2).pdf · JAA NATURALS CANADA 510 Rowntree Dairy Road, Building J, Woodbridge, ON L4L

D

1

issolution characteristics to bioavailability of a solid dosage will vary with factor of formulation or by manufacturing process. It can be use to identify bioequivalence problems and can serve as a signal of bioequivalence as well. Jaapharm dissolution systems are state of the art fully automated in Canadian pharma industry.

1 Vessels creating gastro-dissolution conditions measuring drug levels to the plasma from intestine bypassing the stomach (gastro track) resulting in no side effects.Auto sampler with 8 designated tubes for each vessel collecting sample at assigned intermissions and delivering to Agilant UV-Visible Spectrophotometre.Agilant UV-Visible Spectrophotometre analysing each sample instantly and send results to the PC system. PC Systems linked to dissolution systems.

5

HPLC systems for method development.

2

3

4

5

2 3 4

6 Reasons Why:

All Raw materials, Finished products are tested in house & released by QA before use.

Products are Mfg. at Jaapharm CGMP** facility in Canada License 300109 issued by NHPD***.

Finished products are also tested for dissolution under USP Monographin house.

All products are on stability, dissolution & microbial testing program.

Packaging is done at Jaapharm CGMP** facility in CanadaLicense 300109 issued by NHPD***.

POTASSIUM Gluconate 468 mg TABLETS

Potassium is used as a treatment or prevention of hypokalemia (potassium depletion).For treatment of digitalis toxicity. Used as Potassium replacement therapy.Used as Electrolyte replenisher. Halal & Kosher, no animal by-product nor gelatin, glutin, sweetner, colour, preservative or oil.

Actual Size

Smallest Potassium Gluconate 468 mgcoated tablet in Canada. Highest single dose allowedby Health Canada(NHPD).

*HDFC - High Density Force Compression**CGMP- Current Good Manufacturing Practices according to Health Canada***NHPD - Natural Health Products Directorate (Health Canada)

^

^Your trademark will be embossed.

NPN# 8005804Thin layer HDFC* enteric coating. It’s Chloride free which makes it more suitable for high blood pressure & heart condition patients.

Let us be your

3rd Party

Researcher,

Manufacturer

& Packager

YOUR TRADE NAME

JAA NATURALS CANADA510 Rowntree Dairy Road, Building J, Woodbridge, ON L4L 8H2Tel: 905-851-7885 Fax: 905-856-5838 Email: [email protected] Website: www.jaapahrm.com

®

Page 4: POTASSIUM Gluconate 468 mg TABLETS NPN# …jaapharm.com/products/human/POTASSIUM_TABLETS_(JAA_K2).pdf · JAA NATURALS CANADA 510 Rowntree Dairy Road, Building J, Woodbridge, ON L4L

D

1

issolution characteristics to bioavailability of a solid dosage will vary with factor of formulation or by manufacturing process. It can be use to identify bioequivalence problems and can serve as a signal of bioequivalence as well. Jaapharm dissolution systems are state of the art fully automated in Canadian pharma industry.

1 Vessels creating gastro-dissolution conditions measuring drug levels to the plasma from intestine bypassing the stomach (gastro track) resulting in no side effects.Auto sampler with 8 designated tubes for each vessel collecting sample at assigned intermissions and delivering to Agilant UV-Visible Spectrophotometre.Agilant UV-Visible Spectrophotometre analysing each sample instantly and send results to the PC system. PC Systems linked to dissolution systems.

5

HPLC systems for method development.

2

3

4

5

2 3 4

6 Reasons Why:

All Raw materials, Finished products are tested in house & released by QA before use.

Products are Mfg. at Jaapharm CGMP** facility in Canada License 300109 issued by NHPD***.

Finished products are also tested for dissolution under USP Monographin house.

All products are on stability, dissolution & microbial testing program.

Packaging is done at Jaapharm CGMP** facility in CanadaLicense 300109 issued by NHPD***.

*HDFC - High Density Force Compression**CGMP- Current Good Manufacturing Practices according to Health Canada***NHPD - Natural Health Products Directorate (Health Canada)

Helps to form red blood cells and helps in their proper function.Helps to prevent iron deficiency (anemia). Helps pregnant women meet the Halal & Kosher, no animal by-product nor gelatin, glutin, recommended intake for iron. sweetner, colour, preservative or oil.

Enteric coated to prevent stomach irritation. IRON 45 mg TABLETS NPN# 8000350

FEROFATE

Actual Size

Smallest IRON 45mg coated tablet in Canada. Highest single dose allowedby Health Canada(NHPD).

JAA NATURALS CANADA510 Rowntree Dairy Road, Building J, Woodbridge, ON L4L 8H2Tel: 905-851-7885 Fax: 905-856-5838 Email: [email protected] Website: www.jaapahrm.com

®

Page 5: POTASSIUM Gluconate 468 mg TABLETS NPN# …jaapharm.com/products/human/POTASSIUM_TABLETS_(JAA_K2).pdf · JAA NATURALS CANADA 510 Rowntree Dairy Road, Building J, Woodbridge, ON L4L

JAA NATURALS CANADA 510 Rowntree Dairy Road, Building J, Woodbridge, ON L4L 8H2Tel: 905-851-7885 Fax: 905-856-5838 Email: [email protected] Website: www.jaapahrm.com

6 Reasons Why:

All Raw materials, Finished products are tested in house & released by QA before use.

Products are Mfg. at Jaapharm CGMP** facility in Canada License 300109 issued by NHPD***.

Finished products are also tested for dissolution under USP Monographin house.

All products are on stability, dissolution & microbial testing program.

Packaging is done at Jaapharm CGMP** facility in CanadaLicense 300109 issued by NHPD***.

IRON 45 MG TABLETS

Smallest IRON 45mg coated tablet in Canada. Highest single dose allowedby Health Canada(NHPD).

*HDFC - High Density Force Compression**CGMP- Current Good Manufacturing Practices according to Health Canada***NHPD - Natural Health Products Directorate (Health Canada)

Actual Size

Helps to form red blood cells and helps in their proper function.Helps to prevent iron deficiency (anemia). Helps pregnant women meet the Halal & Kosher, no animal by-product nor gelatin, glutin, recommended intake for iron. sweetner, colour, preservative or oil.

Enteric coated to prevent stomach irritation. NPN# 8000350 Let us be your

3rd Party

Researcher,

Manufacturer

& Packager

5

1 2 3 4

D issolution characteristics to bioavailability of a solid dosage will vary with factor of formulation or by manufacturing process. It can be use to identify bioequivalence problems and can serve as a signal of bioequivalence as well. Jaapharm dissolution systems are state of the art fully automated in Canadian pharma industry.

1 Vessels creating gastro-dissolution conditions measuring drug levels to the plasma from intestine bypassing the stomach (gastro track) resulting in no side effects.Auto sampler with 8 designated tubes for each vessel collecting sample at assigned intermissions and delivering to Agilant UV-Visible Spectrophotometre.Agilant UV-Visible Spectrophotometre analysing each sample instantly and send results to the PC system. PC Systems linked to dissolution systems.HPLC systems for method development.

2

3

4

5

^

^Your trademark will be embossed.

®

Page 6: POTASSIUM Gluconate 468 mg TABLETS NPN# …jaapharm.com/products/human/POTASSIUM_TABLETS_(JAA_K2).pdf · JAA NATURALS CANADA 510 Rowntree Dairy Road, Building J, Woodbridge, ON L4L

D

1

issolution characteristics to bioavailability of a solid dosage will vary with factor of formulation or by manufacturing process. It can be use to identify bioequivalence problems and can serve as a signal of bioequivalence as well. Jaapharm dissolution systems are state of the art fully automated in Canadian pharma industry.

1 Vessels creating gastro-dissolution conditions measuring drug levels to the plasma from intestine bypassing the stomach (gastro track) resulting in no side effects.Auto sampler with 8 designated tubes for each vessel collecting sample at assigned intermissions and delivering to Agilant UV-Visible Spectrophotometre.Agilant UV-Visible Spectrophotometre analysing each sample instantly and send results to the PC system. PC Systems linked to dissolution systems.

5

HPLC systems for method development.

2

3

4

5

2 3 4

6 Reasons Why:

All Raw materials, Finished products are tested in house & released by QA before use.

Products are Mfg. at Jaapharm CGMP** facility in Canada License 300109 issued by NHPD***.

Finished products are also tested for dissolution under USP Monographin house.

All products are on stability, dissolution & microbial testing program.

Packaging is done at Jaapharm CGMP** facility in CanadaLicense 300109 issued by NHPD***.

Smallest Melatonin3 mg coated tablet in Canada.

*HDFC - High Density Force Compression**CGMP- Current Good Manufacturing Practices according to Health Canada***NHPD - Natural Health Products Directorate (Health Canada)

Increases sleep time. Reduces the time to fall asleep.Helps to relieve the daytime fatigue associated with jet lag. Helps re-set the body’s sleep- Halal & Kosher, no animal by-product nor gelatin, glutin, wake cycle. sweetner, colour, preservative or oil.

MELATONIN 3 mg TABLETS NPN# 8001939SLEEP AID

Enteric coated to prevent stomach irritation.

Actual Size

JAA NATURALS CANADA510 Rowntree Dairy Road, Building J, Woodbridge, ON L4L 8H2Tel: 905-851-7885 Fax: 905-856-5838 Email: [email protected] Website: www.jaapahrm.com

®

Page 7: POTASSIUM Gluconate 468 mg TABLETS NPN# …jaapharm.com/products/human/POTASSIUM_TABLETS_(JAA_K2).pdf · JAA NATURALS CANADA 510 Rowntree Dairy Road, Building J, Woodbridge, ON L4L

D

1

issolution characteristics to bioavailability of a solid dosage will vary with factor of formulation or by manufacturing process. It can be use to identify bioequivalence problems and can serve as a signal of bioequivalence as well. Jaapharm dissolution systems are state of the art fully automated in Canadian pharma industry.

1 Vessels creating gastro-dissolution conditions measuring drug levels to the plasma from intestine bypassing the stomach (gastro track) resulting in no side effects.Auto sampler with 8 designated tubes for each vessel collecting sample at assigned intermissions and delivering to Agilant UV-Visible Spectrophotometre.Agilant UV-Visible Spectrophotometre analysing each sample instantly and send results to the PC system. PC Systems linked to dissolution systems.

5

HPLC systems for method development.

2

3

4

5

2 3 4

6 Reasons Why:

All Raw materials, Finished products are tested in house & released by QA before use.

Products are Mfg. at Jaapharm CGMP** facility in Canada License 300109 issued by NHPD***.

Finished products are also tested for dissolution under USP Monographin house.

All products are on stability, dissolution & microbial testing program.

Packaging is done at Jaapharm CGMP** facility in CanadaLicense 300109 issued by NHPD***.

Smallest Melatonin3 mg coated tablet in Canada.

*HDFC - High Density Force Compression**CGMP- Current Good Manufacturing Practices according to Health Canada***NHPD - Natural Health Products Directorate (Health Canada)

Increases sleep time. Reduces the time to fall asleep.Helps to relieve the daytime fatigue associated with jet lag. Helps re-set the body’s sleep- Halal & Kosher, no animal by-product nor gelatin, glutin, wake cycle. sweetner, colour, preservative or oil.

MELATONIN 3 MG TABLETS NPN# 8001939

Enteric coated to prevent stomach irritation. Let us be your3rd Party Researcher, Manufacturer & Packager

Actual Size

^

^Your trademark will be embossed.

JAA NATURALS CANADA510 Rowntree Dairy Road, Building J, Woodbridge, ON L4L 8H2Tel: 905-851-7885 Fax: 905-856-5838 Email: [email protected] Website: www.jaapahrm.com

®

Page 8: POTASSIUM Gluconate 468 mg TABLETS NPN# …jaapharm.com/products/human/POTASSIUM_TABLETS_(JAA_K2).pdf · JAA NATURALS CANADA 510 Rowntree Dairy Road, Building J, Woodbridge, ON L4L

FRIABILITY TEST FOR TABLETSFriction and shock are the forces that most often cause tablets to chip, cap or break. The friability test is closely related to tablet hardness and is designed to evaluate the ability of the tablet to withstand abrasion in packaging, handling and shipping. The loss should not exceed more than 1.0% USP Std.

Competitor product was tested as shown in Picture having over 5.0% Friability result for a Chondroitin Glucosamine 900mg formulation.

Jaapharm product CON-GLU-900 V as shown in Picture has Friablilty result of 0.25%.

All tablets manufactured by Jaapharm are tested for Friability before packaging and all of them confirm to USP Std. i.e. less than 1.0%.

1 2

1

2

JAA NATURALS CANADA510 Rowntree Dairy Road, Building J, Woodbridge, ON L4L 8H2Tel: 905-851-7885 Fax: 905-856-5838 Email: [email protected] Website: www.jaapahrm.com

®