Nitrogen

Nitrogen
SPL v9
SPL
SPL Set ID 74a94613-d970-1596-e053-2991aa0a3290
Route
RESPIRATORY (INHALATION)
Published
Effective Date 2018-08-30
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Nitrogen (990 mL)

Identifiers & Packaging

Marketing Status
NDA Active Since 2018-08-30

Description

Certificate of Analysis By Air-Liquefaction Process Product: NITROGEN NF* Manufacturing Plant: Pryor, OK Address: Hwy 69A & 412 B Pryor, OK 74361 Date / Time: 8/16/2018 9:43:00 AM Lot Number: 037-08/16/2018/09:43 Delivery Unit # (Tanker / Railcar): 037 Quantity / Level / Prossure Gross: 31245 Tare: Net: LBS *NF/EP applies only when used in a medical application or by medical customers properly registered with the FDA Product delivered has been tested for indicated parameters and satisfies the contractually guaranteed purity specifications. Results are nominal values within statistical accuracy of analytical test methods. This certificate does not add to or replace the warranty, limitations of liablilty or other provisions of the agreement between parties. Requirement Test Method Specification Limit Result Nitrogen Diff ≥ 99.999 percent ≥ 99.999 percent Oxygen ** Delta F FAH0100 ≤ 5.00 ppm .68 ppm Odor ** Organoleptic None None Ppm = parts per million by volume ppb = parts per billion by volume *Analysis on storage tank on periodic basis **Analysis of each delivery unit Released By: Released via Electronic Signature: no handwritten signature required (Signature) Kevin N. Shue (Printed Name) QA-046US (08/17) USJS0I00239193000 AutoLand TM


Medication Information

Description

Certificate of Analysis By Air-Liquefaction Process Product: NITROGEN NF* Manufacturing Plant: Pryor, OK Address: Hwy 69A & 412 B Pryor, OK 74361 Date / Time: 8/16/2018 9:43:00 AM Lot Number: 037-08/16/2018/09:43 Delivery Unit # (Tanker / Railcar): 037 Quantity / Level / Prossure Gross: 31245 Tare: Net: LBS *NF/EP applies only when used in a medical application or by medical customers properly registered with the FDA Product delivered has been tested for indicated parameters and satisfies the contractually guaranteed purity specifications. Results are nominal values within statistical accuracy of analytical test methods. This certificate does not add to or replace the warranty, limitations of liablilty or other provisions of the agreement between parties. Requirement Test Method Specification Limit Result Nitrogen Diff ≥ 99.999 percent ≥ 99.999 percent Oxygen ** Delta F FAH0100 ≤ 5.00 ppm .68 ppm Odor ** Organoleptic None None Ppm = parts per million by volume ppb = parts per billion by volume *Analysis on storage tank on periodic basis **Analysis of each delivery unit Released By: Released via Electronic Signature: no handwritten signature required (Signature) Kevin N. Shue (Printed Name) QA-046US (08/17) USJS0I00239193000 AutoLand TM

Section 51945-4

Certificate of Analysis

By Air-Liquefaction Process

Product: NITROGEN NF*

Manufacturing Plant: Pryor, OK

Address: Hwy 69A & 412 B

Pryor, OK 74361

Date / Time: 8/16/2018 9:43:00 AM

Lot Number: 037-08/16/2018/09:43

Delivery Unit # (Tanker / Railcar): 037

Quantity / Level / Prossure Gross: 31245 Tare: Net: LBS

*NF/EP applies only when used in a medical application or by medical customers properly registered with the FDA

Product delivered has been tested for indicated parameters and satisfies the contractually guaranteed purity specifications. Results are nominal values within statistical accuracy of analytical test methods.

This certificate does not add to or replace the warranty, limitations of liablilty or other provisions of the agreement between parties.

Requirement Test Method Specification Limit Result

Nitrogen Diff ≥ 99.999 percent ≥ 99.999 percent

Oxygen ** Delta F FAH0100 ≤ 5.00 ppm .68 ppm

Odor ** Organoleptic None None

Ppm = parts per million by volume ppb = parts per billion by volume

*Analysis on storage tank on periodic basis

**Analysis of each delivery unit

Released By:

Released via Electronic Signature: no handwritten signature required

(Signature)

Kevin N. Shue

(Printed Name)

QA-046US (08/17)

USJS0I00239193000 AutoLand TM


Structured Label Content

Section 51945-4 (51945-4)

Certificate of Analysis

By Air-Liquefaction Process

Product: NITROGEN NF*

Manufacturing Plant: Pryor, OK

Address: Hwy 69A & 412 B

Pryor, OK 74361

Date / Time: 8/16/2018 9:43:00 AM

Lot Number: 037-08/16/2018/09:43

Delivery Unit # (Tanker / Railcar): 037

Quantity / Level / Prossure Gross: 31245 Tare: Net: LBS

*NF/EP applies only when used in a medical application or by medical customers properly registered with the FDA

Product delivered has been tested for indicated parameters and satisfies the contractually guaranteed purity specifications. Results are nominal values within statistical accuracy of analytical test methods.

This certificate does not add to or replace the warranty, limitations of liablilty or other provisions of the agreement between parties.

Requirement Test Method Specification Limit Result

Nitrogen Diff ≥ 99.999 percent ≥ 99.999 percent

Oxygen ** Delta F FAH0100 ≤ 5.00 ppm .68 ppm

Odor ** Organoleptic None None

Ppm = parts per million by volume ppb = parts per billion by volume

*Analysis on storage tank on periodic basis

**Analysis of each delivery unit

Released By:

Released via Electronic Signature: no handwritten signature required

(Signature)

Kevin N. Shue

(Printed Name)

QA-046US (08/17)

USJS0I00239193000 AutoLand TM


Advanced Ingredient Data


Raw Label Data

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